FDA Regulation of Medical Devices
Judith A. Johnson
Specialist in Biomedical Policy
June 25, 2012
Congressional Research Service
7-5700
www.crs.gov
R42130
CRS Report for Congress
Pr
epared for Members and Committees of Congress
FDA Regulation of Medical Devices
Summary
Update: On June 20, 2012, the House of Representatives passed, by voice vote and under
suspension of the rules, S. 3187 (EAH), the Food and Drug Administration Safety and Innovation
Act, as amended. This bill would reauthorize the FDA prescription drug and medical device user
fee programs (which would otherwise expire on September 30, 2012), create new user fee
programs for generic and biosimilar drug approvals, and make other revisions to other FDA drug
and device approval processes. It reflects bicameral compromise on earlier versions of the bill (S.
3187 [ES], which passed the Senate on May 24, 2012, and H.R. 5651 [EH], which passed the
House on May 30, 2012). The following CRS reports provide overview information on FDA’s
processes for approval and regulation of drugs:
• CRS Report R41983, How FDA Approves Drugs and Regulates Their Safety and
Effectiveness, by Susan Thaul.
• CRS Report RL33986, FDA’s Authority to Ensure That Drugs Prescribed to
Children Are Safe and Effective, by Susan Thaul.
• CRS Report R42130, FDA Regulation of Medical Devices, by Judith A. Johnson.
• CRS Report R42508, The FDA Medical Device User Fee Program, by Judith A.
Johnson.
(Note: The rest of this report has not been updated since December 28, 2011.)
Prior to and since the passage of the Medical Device Amendments of 1976, Congress has debated
how best to ensure that consumers have access, as quickly as possible, to new and improved
medical devices and, at the same time, prevent devices that are not safe and effective from
entering or remaining on the market. Medical devices regulation is complex, in part, because of
the wide variety of items that are categorized as medical devices; examples range from a simple
tongue depressor to a life-sustaining heart valve. The regulation of medical devices can affect
their cost, quality, and availability in the health care system.
In order to be legally marketed in the United States, many medical devices must be reviewed by
the Food and Drug Administration (FDA), the agency responsible for protecting the public health
by overseeing medical products, including devices. FDA’s Center for Devices and Radiological
Health (CDRH) is primarily responsible for medical device review. CDRH activities are funded
through a combination of public money (i.e., direct FDA appropriations from Congress) and
private money (i.e., user fees collected from device manufacturers) which together comprise
FDA’s total. User fees account for 33% of FDA’s total FY2011 program level and 15% of
CDRH’s program level, which is $378 million in FY2011 including $56 million in user fees.
FDA’s authority to collect user fees, originally authorized in 2002 (P.L. 107-250), has been
reauthorized in five-year increments. It will expire on October 1, 2012, under the terms of the
Medical Device User Fee Act of 2007 (MDUFA), Title II of the FDA Amendments Act of 2007
(FDAAA, P.L. 110-85).
FDA requires all medical product manufacturers to register their facilities, list their devices with
FDA, and follow general controls requirements. FDA classifies devices according to the risk they
pose to consumers. Premarket review is required for moderate- and high-risk devices. There are
two paths that manufacturers can use to bring such devices to market. One path consists of
conducting clinical studies, submitting a premarket approval (PMA) application and requires
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FDA Regulation of Medical Devices
evidence providing reasonable assurance that the device is safe and effective. The other path
involves submitting a 510(k) notification demonstrating that the device is substantially equivalent
to a device already on the market (a predicate device) that does not require a PMA. The 510(k)
process results in FDA clearance and tends to be much less expensive and less time-consuming
than seeking FDA approval via PMA. Substantial equivalence is determined by comparing the
performance characteristics of a new device with those of a predicate device; clinical data
demonstrating safety and effectiveness are usually not required. Once approved or cleared for
marketing, manufacturers must comply with regulations on manufacturing, labeling, surveillance,
device tracking, and adverse event reporting.
Problems related to medical devices can have serious consequences for consumers. Defects in
medical devices, such as artificial hips and pacemakers, have caused severe patient injuries and
deaths. In 2006, FDA reported 116,086 device-related injuries, 96,485 malfunctions, and 2,830
deaths; an analysis by the National Research Center for Women & Families claims there were
4,556 device-related deaths in 2009. Reports published in 2009 through 2011—by the
Government Accountability Office (GAO), the Department of Health and Human Services Office
of the Inspector General and the Institute of Medicine—have voiced concerns about FDA’s device
review process. In 2009 and 2011 GAO included FDA’s oversight of medical products on the
GAO list of high-risk areas. FDA has conducted internal reviews as well and is implementing
changes.
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FDA Regulation of Medical Devices
Contents
Introduction...................................................................................................................................... 1
The Medical Device Review Process: Premarket Requirements..................................................... 3
Device Classification................................................................................................................. 4
Medical Device Marketing Applications................................................................................... 7
510(k) Notification.............................................................................................................. 8
Premarket Approval (PMA) .............................................................................................. 11
The Medical Device Review Process: Post-Market Requirements ............................................... 13
Labeling................................................................................................................................... 13
Manufacturing ......................................................................................................................... 14
Postmarketing Surveillance ..................................................................................................... 15
Postmarket Surveillance.................................................................................................... 15
Adverse Event Reporting .................................................................................................. 15
Medical Device Tracking .................................................................................................. 16
The Sentinel Initiative ....................................................................................................... 17
Unique Device Identification ............................................................................................ 18
Compliance and Enforcement ................................................................................................. 19
Inspection .......................................................................................................................... 19
Warning Letter................................................................................................................... 20
Product Recall ................................................................................................................... 20
Tables
Table 1. Medical Device Classification ........................................................................................... 5
Table 2. CDRH, FDA Foreign and Domestic Inspections, FY2004–FY2010............................... 19
Table 3. CDRH Warning Letters Issued, FY2000–FY2010 .......................................................... 20
Table 4. CDRH Class I, II, and III Product Recalls, FY2004–FY2010......................................... 21
Appendixes
Appendix A. History of Laws Governing Medical Device Regulation ......................................... 22
Appendix B. Acronyms Used in this Report.................................................................................. 28
Contacts
Author Contact Information........................................................................................................... 29
Congressional Research Service
FDA Regulation of Medical Devices
Introduction
Update: On June 20, 2012, the House of Representatives passed, by voice vote and under suspension of the rules, S.
3187 (EAH), the Food and Drug Administration Safety and Innovation Act, as amended. This bill would reauthorize
the FDA prescription drug and medical device user fee programs (which would otherwise expire on September 30,
2012), create new user fee programs for generic and biosimilar drug approvals, and make other revisions to other
FDA drug and device approval processes. It reflects bicameral compromise on earlier versions of the bill (S. 3187
[ES], which passed the Senate on May 24, 2012, and HR 5651 [EH], which passed the House on May 30, 2012). The
fol owing CRS reports provide overview information on FDA’s processes for approval and regulation of drugs:
•
CRS Report R41983, How FDA Approves Drugs and Regulates Their Safety and Effectiveness, by Susan Thaul.
•
CRS Report RL33986, FDA’s Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective, by Susan
Thaul.
•
CRS Report R42130, FDA Regulation of Medical Devices, by Judith A. Johnson.
•
CRS Report R42508, The FDA Medical Device User Fee Program, by Judith A. Johnson.
(Note: The rest of this report has not been updated since December 28, 2011.)
Medical device regulation is complex, in part because of the wide variety of items that are
categorized as medical devices. They may be simple tools used during medical examinations,
such as tongue depressors and thermometers, or high-tech life-saving implants like heart valves
and coronary stents. The medical device market has been characterized as including eight
industry sectors: surgical and medical instrument manufacturing, surgical appliance and supplies,
in vitro diagnostic products (IVDs, or laboratory tests), electromedical and electrotherapeutic
apparatus, irradiation apparatus, dental equipment and supplies, ophthalmic goods, and dental
laboratories.1
The federal agency primarily responsible for regulating medical devices is the Food and Drug
Administration (FDA)—an agency within the Department of Health and Human Services (HHS).
A manufacturer must receive FDA permission before its device can be legally marketed in the
United States. FDA’s Center for Devices and Radiological Health (CDRH) is primarily
responsible for medical device review. Another center, the Center for Biologics Evaluation and
Research (CBER), regulates devices associated with blood collection and processing procedures,
cellular products and tissues.2
CDRH activities are funded through a combination of public money (i.e., direct FDA
appropriations from Congress) and private money (i.e., user fees collected from device
manufacturers) which together comprise FDA’s total.3 User fees may be used only to support
product review activities, not other CDRH activities. User fees account for 33% of FDA’s total
FY2011 program level and 15% of CDRH’s program level, which is $378 million in FY2011
including $56 million in user fees.4 Congress has reauthorized in five-year increments FDA
1 The Lewin Group, for AdvaMed, State Economic Impact of the Medical Technology Industry, June 7, 2010, p. 19.
2 Jurisdiction of the centers’ medical device review is governed by the FDA Intercenter Agreement between CBER and
CDRH (October 31, 1991). FDA, Devices Regulated by the Center for Biologics Evaluation and Research,
http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/510kProcess/ucm133429.htm.
3 For more information on FDA’s budget, see CRS Report R41737, Public Health Service (PHS) Agencies: Overview
and Funding, FY2010-FY2012, coordinated by C. Stephen Redhead and Pamela W. Smith; and, CRS Report RL34334,
The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007, coordinated by Judith A. Johnson.
4 FDA also funds some device and radiological health activities with fees collected under the Mammography Quality
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collection of medical device user fees; authority will expire on October 1, 2012 under the terms
of the Medical Device User Fee Act of 2007 (MDUFA), Title II of the FDA Amendments Act of
2007 (FDAAA, P.L. 110-85).
Congress has historically been interested in balancing the goals of allowing consumers to have
access, as quickly as possible, to new and improved medical devices with preventing devices that
are not safe and effective from entering or remaining on the market. The goals of device
availability and device safety may exert opposite pulls, with implications for consumers, the
health care system, and the economy.
Investment in medical device development reportedly reached a high of $3.690 billion in 2007.
Investment has slowed somewhat to $2.380 billion in 2010, and $1.510 billion in the first two
quarters of 2011.5 According to one report, the medical technology industry is a “vibrant and
growing contributor to the U.S. economy, generating US$197 billion in revenue and employing
over a half million workers in 2009 alone.”6 “Medical technology industry” includes “medical
device, diagnostic, drug delivery and analytic/life science tool companies but excludes
distributors and service providers” such as contract research or contract manufacturing
organizations.7 Another analysis found that “32 of the 46 medical technology companies with
more than $1 billion in annual revenue are based in the United States.”8 Although the largest
companies dominate the market for devices in terms of sales, it is often the small device
companies that make a significant contribution to early innovation. Small companies may partner
with larger companies to bring products to market if they lack access to the capital and resources
to conduct clinical trials and navigate regulatory and reimbursement hurdles.
Manufacturers make decisions about pursuing new devices based in part on the cost of their
development. Additional regulatory requirements may escalate these costs, while other incentives,
such as tax breaks or market exclusivity extensions, may diminish them. If the device
development cost is too high, the eventual result may be that consumers are denied access
because new products are not developed or brought to market. Access problems have led to
proposals for, and the enactment of, incentives to develop medical devices for rare diseases and
pediatric populations. However, if the regulation and oversight of device development are not
stringent enough, unsafe or ineffective products may reach the market and cause harm to
consumers.
Problems related to medical devices can have serious consequences for consumers. Defects in
medical devices, such as artificial hips, pacemakers, defibrillators, and stents, have caused severe
patient injuries and deaths.9 In 2006, FDA reported 116,086 device-related injuries, 96,485
(...continued)
Standards Act (MQSA, P.L. 102-539), and device user fees fund some non–device-specific activities at FDA.
5 PriceWaterhouseCoopers / National Venture Capital Association, “Medical Devices and Equipment,” Money Tree
Report, data provided by Thomson Reuters, at http://www.pwcmoneytree.com.
6 Ernst and Young. 2010. Pulse of the industry: Medical technology report, p. 15.
7 Ibid., p. 87.
8 PwC (PricewaterhouseCoopers), Medical Technology Innovation Scorecard: The race for global leadership, January
2011, p. 8, http://www.pwc.com/us/en/health-industries/health-research-institute/innovation-scorecard.
9 For example, see Barry Meier and Janet Roberts, “Hip implant complaints surge, even as the dangers are studied,”
The New York Times, August 22, 2011, pp. A1, A16; Information on recalls is available by searching the database at
FDA, Medical & Radiation Emitting Device Recalls, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm.
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malfunctions, and 2,830 deaths; a more recent independent analysis claims there were 4,556
device-related deaths in 2009.10 Consequences such as these have raised questions as to whether
adequate enforcement tools, resources, and processes are in place to ensure that marketed devices
are safe. Reports by the Government Accountability Office (GAO), the Department of Health and
Human Services Office of the Inspector General, and the Institute of Medicine (IOM) have
voiced concerns about FDA’s device review process.11 In 2009 and in 2011 GAO included FDA’s
oversight of medical products on the GAO list of high-risk areas.12
This report provides a description of FDA’s medical device review process divided into two parts:
premarket requirements and postmarket requirements. Appendix A provides a brief history of
laws governing medical device regulation and Appendix B provides a table of acronyms used in
the report.
The Medical Device Review Process:
Premarket Requirements
FDA requires all medical product manufacturers to register their facilities, list their devices with
the agency, and follow general controls requirements.13 FDA classifies devices according to the
risk they pose to consumers. Many medical devices, such as plastic bandages and ice bags,
present only minimal risk and can be legally marketed upon registration alone. These low-risk
devices are deemed exempt from premarket review and manufacturers need not submit an
application to FDA prior to marketing.14 In
contrast, most moderate- and high-risk devices
PMA vs. 510(k)
must obtain the agency’s permission prior to
There is a fundamental difference between the PMA
marketing. FDA grants this permission when a
and 510(k) pathways. In a PMA review, FDA
manufacturer meets regulatory premarket
determines if the device is reasonably safe and
effective for its intended use. In a 510(k) review,
requirements and agrees to any necessary
FDA determines if the device is substantially
postmarket requirements which vary according to
equivalent to another device whose safety and
the risk that a device presents.15
effectiveness may never have been assessed.
10 FDA, CDRH Reports, OCD FY2006: FDA Goal 3-Improving Product Quality, Safety, and Availability Through
Better Manufacturing and Product Oversight, at http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/
ucm129324.htm; and Statement of Diana Zuckerman, PhD, President of the National Research Center for Women &
Families at the House of Representatives Briefing on Medical Devices, May 17, 2011, at
http://www.center4research.org/2011/05/statement-of-diana-zuckerman-phd-president-of-the-national-research-center-
for-women-families-at-a-house-of-representatives-briefing-on-medical-devices/.
11 U.S. Government Accountability Office, Medical Devices: FDA should take steps to ensure that high-risk device
types are approved through the most stringent premarket review process, GAO-09-190, January 2009; Daniel R.
Levinson, Adverse Event Reporting for Medical Devices, Department of Health and Human Services, Office of
Inspector General, Washington, DC, October 2009; and, IOM (Institute of Medicine), Medical Devices and the
Public’s Health: The FDA 510(k) Clearance Process at 35 Years, Washington, DC, July 2011.
12 GAO regularly reports on government operations that it identifies as high risk due to their greater vulnerability to
fraud, waste, abuse, mismanagement or the need for transformation to address economy, efficiency or effectiveness
challenges. See GAO, High-Risk Series: An Update, GAO-09-271, January 2009; and GAO, High-Risk Series: An
Update, GAO-11-278, February 2011.
13 (21 CFR 862-892).
14 The term manufacturer is used throughout this report for simplicity, but regulations also apply to any person,
organization, or sponsor that submits an application to FDA to market a device.
15 In vitro diagnostic products (IVDs, or laboratory tests) have their own unique premarket requirements and are not
(continued...)
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There are two paths that manufacturers can use to bring their moderate- and high-risk devices to
market with FDA’s permission. One path consists of conducting clinical studies, submitting a
premarket approval (PMA) application and requires evidence providing reasonable assurance that
the device is safe and effective.16 The PMA process is generally used for novel and high-risk
devices and is typically lengthy and expensive. It results in a type of FDA permission called
approval.
The other path involves submitting a 510(k) notification demonstrating that the device is
substantially equivalent to a device already on the market (a predicate device) that does not
require a PMA.17 The 510(k) process is unique to medical devices and results in FDA clearance.
Substantial equivalence is determined by comparing the performance characteristics of a new
device with those of a predicate device. To be considered substantially equivalent, the new device
must have the same intended use and technological characteristics as the predicate; clinical data
demonstrating safety and effectiveness are usually not required. The manufacturer selects the
predicate device to compare with its new device. However, FDA has the ultimate discretion in
determining whether a comparison is appropriate.
According to a 2009 GAO report, of the more than 50,000 devices that were listed by
manufacturers with FDA from FY2003 through FY2007, about 67% were exempt from premarket
review; the remainder entered the market via the 510(k) process (31%), the PMA process (1%) or
via other means.18
Device Classification
Under the terms of the Medical Device Amendments of 1976 (MDA, P.L. 94-295), FDA
classified all medical devices that were on the market at the time of enactment—the
preamendment devices—into one of three classes. Congress provided definitions for the three
classes—Class I, Class II, Class III—based on the risk (low-, moderate-, and high-risk
respectively) to patients posed by the devices.19 Examples of each class are listed in Table 1.
Device classification determines the type of regulatory requirements that a manufacturer must
follow. Regulatory requirements for each class are described below in more detail. General
controls, the minimum regulations that apply to all FDA regulated medical devices, include five
elements:20
(...continued)
discussed further in this report.
16 This is somewhat similar to the process FDA uses to approve a new prescription drug. For more information, see
CRS Report R41983, How FDA Approves Drugs and Regulates Their Safety and Effectiveness, by Susan Thaul.
17 To be a predicate, a device must have either been on the market before 1976 when the Medical Device Amendments
(MDA) took effect, or it could have been cleared for marketing after 1976, but must have the same intended use as a
device classified in the Code of Federal Regulations (CFR).
18 U.S. Government Accountability Office, Medical Devices: FDA should take steps to ensure that high-risk device
types are approved through the most stringent premarket review process, GAO-09-190, January 2009, p. 9.
19 FFDCA §513(a)(1); see also 21 CFR §860.3(c). As of 2009, the agency has classified over 1,700 distinct types of
devices. The device types are organized in the Code of Federal Regulations (CFR) in 16 classification panels, such as
“cardiovascular devices” or “ear, nose, and throat devices.” FDA, Device Classification, June 18, 2009,
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm.
20 See FDA, General and Special Controls, April 30, 2009, http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/Overview/GeneralandSpecialControls/default.htm.
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• establishment registration—such as manufacturers, distributors, repackagers and
relabelers, and foreign firms;21
• device listing—listing with FDA of all devices to be marketed;
• good manufacturing practices (GMP)—manufacturing of devices in accordance
with the Quality Systems Regulation (QSR);22
• labeling—labeling of devices or in vitro diagnostic products;23 and
• premarket notification—submission to FDA of a premarket notification 510(k).
Table 1. Medical Device Classification
Device
Safety / Effectiveness
Classification Examples
Controls Required
Submission
Class I
elastic bandages, examination gloves,
General Controls
-Registration only unless 510(k)
and hand-held surgical instruments
specifically required
Class II
powered wheelchairs, infusion pumps, General Controls &
-510(k) clearance unless
and surgical drapes
Special Controls
exempt
-IDE possible
Class III
heart valves, silicone gel-fil ed breast
General Controls &
-PMA approval
implants, and implanted cerebella
Premarket Approval
-IDE probable
stimulators
metal-on-metal hip joint, certain
General Controls
-510(k) clearance
dental implants
Source: FDA, Overview of Medical Device Regulation, General and Special Controls, at http://www.fda.gov/
MedicalDevices/DeviceRegulationandGuidance/Overview/GeneralandSpecialControls/default.htm.
Note: IDE means investigational device exemption.
Class I devices are those under current law for which general controls “are sufficient to provide
reasonable assurance of the safety and effectiveness of the device.”24 Many Class I devices are
exempt from the premarket notification and/or the QSR requirements, though they still have to
comply with the other general controls. A device is exempt if FDA determines that it presents a
low risk of illness or injury to patients.25
Class II devices are those under current law “which cannot be classified as class I because the
general controls by themselves are insufficient to provide reasonable assurance of safety and
effectiveness of the device.”26 Class II includes devices that pose a moderate risk to patients, and
may include new devices for which information or special controls are available to reduce or
mitigate risk. Special controls may include special labeling requirements, mandatory performance
standards, and postmarket surveillance. Currently “15% of all device types classified in Class II
21 21 CFR 807.20
22 21 CFR 820
23 21 CFR 801 or 809.10.
24 FFDCA §513(a)(1)(A).
25 See 21 CFR 862 to 892.
26 FFDCA §513(a)(1)(B).
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are subject to special controls.”27 Although most Class II devices require premarket notification
via the 510(k) process, a few are exempt by regulation.28
Class III devices are those under current law which “cannot be classified as a class I device
because insufficient information exists to determine that the application of general controls are
sufficient to provide reasonable assurance of the safety and effectiveness of the device,” and
“cannot be classified as a class II device because insufficient information exists to determine that
the special controls ... would provide reasonable assurance of [their] safety and effectiveness,”
and are “purported or represented to be for a use in supporting or sustaining human life or for a
use which is of substantial importance in preventing impairment of human health,” or present “a
potential unreasonable risk of illness or injury, [are] to be subject ... to premarket approval to
provide reasonable assurance of [their] safety and effectiveness.”29
In other words, general and/or special controls are not sufficient to assure safe and effective use
of a Class III device. Class III includes devices which are life-supporting or life-sustaining, and
devices which present a high or potentially unreasonable risk of illness or injury to a patient. New
devices that are not classified as Class I or II by another means, are automatically designated as
Class III unless the manufacturer files a request or petition for reclassification.30
Although most Class III devices require premarket approval (PMA), some Class III devices may
be cleared via the 510(k) process. In fact, during the first 10 years following enactment of MDA,
over 80% of postamendment Class III devices entered the market on the basis of 510(k)
submissions showing substantial equivalence to preamendment devices.31 According to FDA,
these are “postamendment (i.e., introduced to the U.S. market after May 28, 1976) Class III
devices which are substantially equivalent to preamendment (i.e., introduced to the U.S. market
before May 28, 1976) Class III devices and for which the regulation calling for the premarket
approval application has not been published in 21 CFR.”32 FDA explains the situation as follows:
When FDA’s medical device regulation program began in the late 1970s, FDA regulated
over 100 Class III device types through the 510(k) program. The intent was that FDA’s
regulation would be temporary and that over time, FDA would decide to reclassify those
device types (or regulations) into Class I or II, or to sustain the classification in Class III and
call for PMA applications. The process of reclassification is described in FDA’s regulations
in Section 515 of the Federal Food, Drug and Cosmetic Act. Over the years, FDA has made
progress in this original list; however, as of 2009, 26 medical device regulations remained in
this transitional state awaiting final classification.33
27 IOM, Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years, Washington, DC,
July 2011, p. 40.
28 FDA, Overview of Medical Device Regulation, Medical Device Classification, Class I/II Exemptions, at
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051549.htm.
29 FFDCA §513(a)(1)(C).
30 FFDCA §513(f)(2).
31 IOM, Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years, Washington, DC,
July 2011, p. 81.
32 FDA, Overview of Medical Device Regulation, General and Special Controls, at http://www.fda.gov/
MedicalDevices/DeviceRegulationandGuidance/Overview/GeneralandSpecialControls/default.htm.
33 FDA, CDRH Transparency, 515 Program Initiative, at http://www.fda.gov/AboutFDA/CentersOffices/CDRH/
CDRHTransparency/ucm240310.htm.
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At the time that the MDA of 1976 was drafted, “relatively few medical devices were permanently
implanted or intended to sustain life. The 510(k) process was specifically intended for devices
with less need for scientific scrutiny, such as surgical gloves and hearing aids.”34 Over time,
FDA’s 510(k) review process was “challenged as new devices changed more dramatically and
became more complex.”35
Examples of Class III devices that are still regulated via the 510(k) program include the metal-on-
metal hip joint, certain dental implants, automated external defibrillator, electroconvulsive
therapy device, pedicle screw spinal system, intra-aortic balloon and control system, and several
device types related to pacemakers.36 In late 2009, FDA implemented the 515 Program Initiative
“to facilitate the final adjudication of these remaining Class III device types.”37
Medical Device Marketing Applications
As stated above, in general, before a non-exempt medical device may be legally marketed, a
manufacturer must submit to FDA either: a PMA application, and the agency approves the device;
or, a 510(k) notification, and the agency clears the device. FDA makes its determination—either
approval or clearance—based on information the manufacturer submits. The information that is
required—in other words, the type of marketing application the manufacturer must make (if
any)—is determined based on the risk that the device poses, if used according to the
manufacturer’s instructions. FDA typically evaluates more than 4,000 510(k) notifications and
about 40 original PMA applications each year.38
The Food and Drug Administration Modernization Act of 1997 (FDAMA; P.L. 105-115) gave
FDA the authority to establish procedures for meeting with manufacturers prior to preparing a
submission.39 The procedures aim to speed the review process by giving FDA and a manufacturer
the opportunity to address questions and concerns about the device and/or the planned studies that
will be used to support the marketing application before the studies are initiated and the
application is submitted. Requests for these meetings have doubled over the past five years
according to testimony by CDRH Director Jeffrey Shuren at a November 2011 Senate hearing.40
34 Diana M. Zuckerman, Paul Brown, and Steven Nissen, “Medical device recalls and the FDA approval process,”
Archives of Internal Medicine, Online publication 2011, p. E2.
35 Ibid., p. E2.
36 FDA, CDRH Transparency, 515 Program Status, at http://www.fda.gov/AboutFDA/CentersOffices/CDRH/
CDRHTransparency/ucm240318.htm.
37 FDA, CDRH Transparency, 515 Program Initiative, at http://www.fda.gov/AboutFDA/CentersOffices/CDRH/
CDRHTransparency/ucm240310.htm.
38 U.S. Congress, Senate Special Committee on Aging, A Delicate Balance: FDA and the Reform of the Medical Device
Approval Process, Testimony of William Maisel, Deputy Center Director for Science, FDA/CDRH, 112th Cong., 1st
sess., April 13, 2011.
39 For guidance on the procedures established, see Early Collaboration Meetings Under the FDA Modernization Act;
Final Guidance for Industry and CDRH Staff, February 28, 2001, at http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/ucm073604.htm.
40 U.S. Congress, Senate Committee on Health, Education, Labor, and Pensions, Medical Devices: Protecting Patients
and Promoting Innovation, 112th Cong., 1st sess., November 15, 2011.
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Generally speaking, under the Federal Food, Drug and Cosmetic Act (FFDCA), manufacturers
• are prohibited from selling an adulterated product;41
• are prohibited from misbranding a product;42
• must register their facility with FDA and list all of the medical devices that they
produce or process (and a fee is now required under the terms of FDAAA);
• must file the appropriate premarket submission with the agency at least 90 days
before introducing a non-exempt device onto the market; and
• must report to FDA any incident that they are aware of that suggests that their
device may have caused or contributed to a death or serious injury.
Under the terms of MDUFA (Title II of FDAAA), manufacturers must pay a fee for most types of
submissions. In 2010, FDA charged $217,787 in user fees to review a PMA ($54,447 for smaller
companies) and $4,007 to review a 510(k) submission ($2,004 for small companies).43 GAO
found that in 2005, the average cost for FDA to review a PMA was $870,000 and the average cost
to review a 510(k) submission was $18,200.44 According to CDRH Director Jeffrey Shuren, user
fees collected under MDUFA “fund only about 20% of the device review program;” in contrast,
users fees collected under the Prescription Drug User Fee Act (PDUFA) “account for about two-
thirds of the drug review program’s budget.”45
510(k) Notification
In general, a 510(k) submission is required for a moderate-risk medical device that is not non-
exempt from premarket review. A 510(k) could also be used for currently marketed devices for
which the manufacturer seeks a new indication (e.g., a new population, such as pediatric use, or a
new disease or condition), or for which the manufacturer has changed the design or technical
characteristics such that the change may affect the performance characteristics of the device.
Between 1996 and 2009, more than 80% of the devices cleared by FDA using 510(k) notification
were Class II devices, about 10% were Class I and less than 5% were Class III.46 A 2009 GAO
report found that 25% of the 10,670 Class II devices cleared by FDA in FY2003 through FY2007
41 A device is adulterated if it includes any filthy, putrid, or decomposed substance, or if it is prepared, packed, or held
under unsanitary conditions. The FFDCA further states that a device is adulterated if its container contains any
poisonous or deleterious substance, or if its strength, purity or quality varies significantly from what the manufacturer
claims. For higher class devices, a device can be considered adulterated if it fails to meet performance requirements
outlined in its approval, or if it is in violation of other Good Manufacturing Practice requirements.
42 A device is misbranded when all or part of the labeling (i.e., the FDA-approved printed material providing
information about the device) is false, misleading, or missing.
43 FDA, “Medical Device User Fee Rates for Fiscal Year 2010,” 74 Federal Register 38444-38449, August 3, 2009;
http://edocket.access.gpo.gov/2009/E9-18456.htm.
44 U.S. Government Accountability Office, Medical Devices: FDA should take steps to ensure that high-risk device
types are approved through the most stringent premarket review process, GAO-09-190, January 2009.
45 U.S. Congress, Senate Committee on Health, Education, Labor, and Pensions, Medical Devices: Protecting Patients
and Promoting Innovation, Testimony of Jeffrey Shuren, Director CDRH, FDA, 112th Cong., 1st sess., November 15,
2011, http://help.senate.gov/imo/media/doc/Shuren.pdf.
46 IOM, Public Health Effectiveness of the FDA 510(k) Clearance Process: Measuring Postmarket Performance and
Other Select Topics, Workshop Report, Washington, DC, 2011, pp. 12 and 78.
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were either implantable, life sustaining or presented significant risk to the health, safety, or
welfare of the patient.47 The agency cleared about 90% of 510(k) submissions reviewed during
FY2003 through FY2007.48
As noted previously, the standard for clearance of a traditional 510(k) is substantial equivalence
with a predicate device. A predicate device can be one of two things. It can be a previously
cleared Class I or II device that does not require a PMA. It can also be preamendment Class III
for which the agency has not issued regulations requiring a PMA. (PMAs, which are more
rigorous submissions than 510(k)s, are discussed in the “Premarket Approval (PMA)” section.)
A manufacturer may choose one
of three types of 510(k)
2011 IOM Report on 510(k) Substantial Equivalence
submissions for premarket
“In practice, the assessment of substantial equivalence general y does not
clearance: traditional, special, or
require evidence of safety or effectiveness of a device. Unlike the
abbreviated.49 A study of 510(k)
premarket approval (PMA) process, by law the 510(k) process, with
some exceptions [see SMDA 1990], focuses solely on the determination
submissions between 1996 and
of a device’s substantial equivalence to a predicate device. According to
2009 found that about 80% were
the FDA and the Supreme Court, when the FDA finds a device
traditional, 16% were special,
substantial y equivalent to a predicate device, it has done no more than
and 3% were abbreviated.50 For
find that the new device is as safe and effective as the predicate. It is
novel devices without a
important to note that devices on the market before the enactment of
the 1976 Medical Device Amendments (MDA)—the origin of all
predicate, there is another
predicate devices for the 510(k) process—have never been systematical y
alternative called the de novo
assessed to determine their safety and effectiveness. Because the
510(k) process.
preamendment device to which equivalence was established was not itself
reviewed for safety or effectiveness, the committee found that clearance
In a traditional 510(k), the
of a 510(k) submission was not a determination that the cleared device
was safe or effective.” See p. 154.
manufacturer submits
information about the
performance of the device under specific conditions of use. It also contains information about the
design of the device, characteristics of device components, representations of packaging and
labeling, a description and summary of the non-clinical and clinical studies that were done to
support the device performance characteristics, a description of means by which users can assess
the quality of the device, and information about any computer software or additional or special
equipment needed. Several administrative forms are also required.51
Most of the studies supporting a 510(k) submission are not clinical studies. Substantial
equivalence, in many cases, means only that the device performs in a similar fashion to the
predicate under a similar set of circumstances. As a result, many devices never have to
demonstrate safety and effectiveness through clinical studies.
47 U.S. Government Accountability Office, Medical Devices: FDA should take steps to ensure that high-risk device
types are approved through the most stringent premarket review process, GAO-09-190, January 2009, p. 18.
48 Ibid., p. 27.
49 FDA, Medical Devices, 510(k) Submission Methods, at http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/
ucm134034.htm
50 IOM, Public Health Effectiveness of the FDA 510(k) Clearance Process: Measuring Postmarket Performance and
Other Select Topics, Workshop Report, Washington, DC, 2011, pp. 12 and 79.
51 FDA, How to Prepare a Traditional 510(k), September 14, 2009; http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/
ucm134572.htm#link_4.
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In addition to not requiring clinical studies, three other characteristics of the 510(k) process make
it much less rigorous than the PMA process: (1) premarket inspections of how devices were
manufactured are generally not required by FDA; (2) postmarket studies are not required by FDA
as a condition of clearance; and, (3) FDA has limited authority to rescind or withdraw clearance if
a 510(k) device is found to be unsafe or ineffective.52
FDA may take any of the following actions on a 510(k) after conducting its review:
• find the device substantially equivalent to the predicate and issue a clearance
letter;
• find the device not substantially equivalent (NSE) and issue an NSE letter
prohibiting marketing;
• determine that the device is exempt from a 510(k) submission;
• request additional information (with the final clearance decision pending review
of that information).53
A manufacturer generally has 30 days to provide any additional information, or FDA may issue a
notice of withdrawal of the application.54 The manufacturer may, at any time, withdraw its
510(k). FDA has 90 days to review a traditional 510(k).55
Abbreviated and special 510(k)s were new approaches to premarket notification that came from
FDAMA. These approaches were intended to streamline and expedite FDA’s review for routine
submissions meeting certain qualifications, thus leaving reviewer time for more complicated
submissions.
An abbreviated 510(k) uses guidance documents developed by FDA to communicate regulatory
and scientific expectations to industry. Guidance documents have been prepared for many
different kinds of devices, and are available on FDA’s website. All guidance documents are
developed in accordance with Good Guidance Practices (GGP), and many with public
participation or opportunities for public comment.56 In addition to issuing guidance documents,
FDA can either develop performance or consensus standards or ‘recognize’ those developed by
outside parties.57 In an abbreviated 510(k), the manufacturer describes what guidance document,
special control, or performance standard was used, and how it was used to assess performance of
their device. Other minimum required elements are the product description, representative
labeling, and a summary of the performance characteristics. FDA typically reviews an
abbreviated 510(k) in 60 days.
52 Diana M. Zuckerman, Paul Brown, and Steven Nissen, “Medical device recalls and the FDA approval process,”
Archives of Internal Medicine, Online publication 2011, p. E4.
53 21 CFR 807.100(a).
54 21 CFR 807.87(l).
55 The FDA time clock (i.e., review cycle) begins when FDA receives the 510(k) and ends with the date that FDA
issues either a request for additional information or a decision. More than one cycle may occur before FDA issues its
final decision.
56 21 CFR 10.115. FDA continually accepts public comment on any draft or final guidance document.
57 21 CFR 861.
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A special 510(k) may be used for a modification to a device that has already been cleared; it
typically uses the design control58 requirement of the Quality System Regulation (QSR). The
QSR describes the good manufacturing practice (GMP) requirements for medical devices.59 The
special 510(k) allows the manufacturer to declare conformance to design controls without
providing the data. This type of submission references the original 510(k) number, and contains
information about the design control requirements. FDA aims to review most special 510(k)s in
30 days.
Under the FFDCA, novel devices lacking a legally marketed predicate are automatically
designated Class III. FDAMA amended FFDCA Section 513(f) to allow FDA to establish a new,
expedited mechanism for reclassifying these devices based on risk, thus reducing the regulatory
burden on manufacturers. The de novo 510(k), though requiring more data than a traditional
510(k), often requires less information than a premarket approval (PMA) application.
In a de novo 510(k) process, the manufacturer submits a traditional 510(k) for its device.
However, because there is no predicate device or classification, the agency will return a decision
of not substantially equivalent. Within 30 days, the manufacturer submits a petition requesting
reclassification of its device into Class II or I, as appropriate. Within 60 days, FDA will render a
decision classifying the device according to criteria in FFDCA Section 513(a)(1). With approval,
FDA issues a regulation that classifies the device. If the device is Class II, a special controls
guidance document is also developed that then allows subsequent manufacturers to submit either
traditional or abbreviated 510(k)s.60 On September 30, 2011, FDA released draft guidance
designed to further streamline the de novo review process.61
Premarket Approval (PMA)
A PMA is the most stringent type of device marketing application required by FDA for new
and/or high-risk devices. PMA approval is based on a determination by FDA that the application
contains sufficient valid scientific evidence to assure that the device is safe and effective for its
intended use(s).62 In contrast to a 510(k), PMAs generally require some clinical data prior to
gaining approval.63 All clinical evaluations of investigational devices (unless exempt) must have
an investigational device exemption (IDE) before the study is initiated.64 An IDE allows an
58 Design controls are a series of predetermined checks, verifications, and specifications that are built into the
manufacturing process to validate the quality of the product throughout the process. These can include defining the
personnel responsible for implementing steps in the development and manufacturing process, defining specifications
and standards for assessing the quality of the materials that go into making the product, designing specifications for
accepting and rejecting different batches or lots of final product, and requirements for maintaining appropriate records.
59 21 CFR 820.30.
60 FDA, New Section 513(f)(2)—Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH
Staff, February 19, 1998, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/
ucm080195.htm.
61 Food and Drug Administration, “FDA Seeks Comment on Streamlined Review of Lower Risk, New Technology,
Devices,” press release, September 30, 2011, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/
ucm274008.htm.
62 21 CFR 814.
63 PMAs can also use studies from the medical literature (a “paper PMA”).
64 See 21 CFR 812. Devices are exempt from IDE requirements when testing is noninvasive, does not require invasive
sampling, does not introduce energy into a subject, and is not stand alone (i.e., is not used for diagnosis without
confirmation by other methods or medically established procedures). See 21 CFR 812.2(c)(3).
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unapproved device (most commonly an invasive or life-sustaining device) to be used in a clinical
study to collect the data required to support a PMA submission.65 The IDE permits a device to be
shipped lawfully for investigation of the device without requiring that the manufacturer comply
with other requirements of the FFDCA, such as registration and listing. In August and in
November 2011 FDA released new draft guidance intended to ensure the quality of clinical trials
and streamline the IDE process by clarifying the criteria for approving clinical trials.66 All clinical
studies must also receive prior approval by an institutional review board (IRB).67
A PMA must contain (among other things) the following information:
• summaries of non-clinical and clinical data supporting the intended use and
performance characteristics;
• detailed information on the device design and device components;
• instructions for use;
• representations of packaging and labeling;
• a description of means by which users can assess the quality of the device;
• information about computer software or additional or special equipment;
• literature about the disease and the similar devices; and,
• information on the manufacturing process.
Approval is based not only on the strength of the scientific data, but also on inspection of the
manufacturing facility to assure that the facility and the manufacturing process are in compliance
with the quality systems regulations (QSR).68 FDAMA made it easier for manufacturers to submit
the required sections of a PMA in a serial fashion as data are available (“modular PMA”).
When a PMA is first received, FDA has 45 days to make sure the application is administratively
complete. If not, the application is returned. If the application is complete, it is formally filed by
FDA. The agency then has 75 days to complete the initial review and determine whether an
advisory committee meeting will be necessary.
Advisory committees can be convened to make recommendations on any scientific or policy
matter before FDA.69 They are comprised of scientific, medical, and statistical experts, and
industry and consumer representatives. An advisory committee meeting allows interested persons
65 FDA, Device Advice: Investigational Device Exemption (IDE), July 9, 2009, http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/default.htm.
66 FDA, “FDA seeks comment on proposed guidance for high-quality clinical studies,” FDA, press release, August 15,
2011, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm268000.htm; and, “FDA issues two draft
guidance documents to facilitate investigational medical device studies in humans,” press release, November 10, 2011,
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm279459.htm.
67 An IRB is a group, generally comprised volunteers, that examines proposed and ongoing scientific research to ensure
that human subjects are properly protected. For further information, see CRS Report RL32909, Federal Protection for
Human Research Subjects: An Analysis of the Common Rule and Its Interactions with FDA Regulations and the HIPAA
Privacy Rule, by Erin D. Williams.
68 21 CFR 820.
69 For further information, see CRS Report RS22691, FDA Advisory Committee Conflict of Interest, by Erin D.
Williams.
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to present information and views at a public hearing.70 FDA typically accepts advisory committee
recommendations for an application (approvable, approvable with conditions, or non-approvable).
However, there have been cases where FDA’s decision has not been consistent with the
committee’s recommendation. CDRH will hold joint advisory committee meetings with other
centers where necessary.
After FDA notifies the applicant that the PMA has been approved or denied, a notice may be
published on the Internet announcing the data on which the decision is based and providing
interested persons an opportunity to petition FDA within 30 days for reconsideration of the
decision. Though FDA regulations allow 180 days to review the PMA and make a determination,
total review time can be much longer.71 MDUFA performance goals have been established to
reduce the review time for PMAs.72
The Medical Device Review Process:
Post-Market Requirements
Once approved or cleared for marketing, manufacturers of medical devices must comply with
various regulations on labeling and advertising, manufacturing, postmarketing surveillance,
device tracking, and adverse event reporting. This section describes those requirements and the
Sentinel Initiative and the unique device identification (UDI) system, which are both under
development, as well as CDRH compliance and enforcement actions.
Labeling
Like drugs and biological products, all FDA approved or cleared medical devices are required to
be labeled in a way that informs a user of how to use the device. The FFDCA defines a “label” as
a “display of written, printed, or graphic matter upon the immediate container of any article.”73
“Labeling” is defined as “all labels and other written, printed, or graphic matter upon any article
or any of its containers or wrappers, or accompanying such article” at any time while a device is
held for sale after shipment or delivery for shipment in interstate commerce.74
70 21 CFR 14.
71 FDA, FY2010 Performance Report to the Congress for the Medical Device User Fee Amendments of 2007,
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/
MDUFMA/UCM243386.pdf. See also 21 CFR 814.40.
72 FDA officials meet with industry leaders to agree upon mutually acceptable fee types, amounts, exceptions, and
performance goals. The agreement specifies that, in return for the additional resources provided by medical device user
fees, FDA is expected to meet performance goals defined in a letter, generally referred to as the “FDA Commitment
Letter,” from the HHS Secretary to the Chairmen and Ranking Minority Members of the Committee on Health,
Education, Labor and Pensions of the U.S. Senate and the Committee on Energy and Commerce of the U.S. House of
Representatives. This process is similar to the one used for prescription drug user fees under the Prescription Drug User
Fee Act (PDUFA). For further information on PDUFA, see CRS Report RL33914, The Prescription Drug User Fee
Act: History Through the 2007 PDUFA IV Reauthorization, by Susan Thaul.
73 FFDCA §201(k)
74 FFDCA §201(m)
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The term “accompanying” is interpreted to mean more than physical association with the product;
it extends to posters, tags, pamphlets, circulars, booklets, brochures, instruction books, direction
sheets, fillers, webpages, etc. Accompanying can also include labeling that is connected with the
device after shipment or delivery for shipment in interstate commerce. According to an appellate
court decision, “most, if not all advertising, is labeling. The term ‘labeling’ is defined in the
FFDCA as including all printed matter accompanying any article. Congress did not, and we
cannot, exclude from the definition printed matter which constitutes advertising.”75
All devices must conform to the general labeling requirements. 76 Certain devices require specific
labeling which may include not only package labeling, but informational literature, patient release
forms, performance testing, and/or specific tolerances or prohibitions on certain ingredients.77
A section of the QSR also has an impact on various aspects of labeling.78 The QSR regulation
applies to the application of labeling to ensure legibility under normal conditions of use over the
expected life of the device and also applies to inspection, handling, storage, and distribution of
labeling. FDA considers a device to be adulterated if these requirements are not met. These
requirements do not apply to the adequacy of labeling content, except to make sure the content
meets labeling specifications contained in the device master record. However, failure to comply
with GMP requirements, such as proofreading and change control, could result in labeling content
errors. In such cases, the device could be misbranded and/or adulterated.
Manufacturing
Like drug manufacturers, medical device manufacturers must produce their devices in accordance
with Good Manufacturing Practice (GMP). The GMP requirements for devices are described in
the QSR.79 The QSRs require that domestic or foreign manufacturers have a quality system for
the design, manufacture, packaging, labeling, storage, installation, and servicing of non-exempt
finished medical devices intended for commercial distribution in the United States. The regulation
requires that various specifications and controls be established for devices; that devices be
designed and manufactured under a quality system to meet these specifications; that finished
devices meet these specifications; that devices be correctly installed, checked and serviced; that
quality data be analyzed to identify and correct quality problems; and that complaints be
processed. FDA monitors device problem data and inspects the operations and records of device
developers and manufacturers to determine compliance with the GMP requirements.80 Though
FDA has identified in QSR the essential elements that a quality system should have,
manufacturers have a great deal of leeway to design quality systems that best cover nuances of
their devices and the means of producing them.
75 United States v. Research Laboratories, Inc., 126 F.2d 42 (9th Cir. 1942).
76 21 CFR 801
77 21 CFR 801.405 to 801.437. Denture repair kits, impact resistant lenses in sunglasses and eyeglasses, ozone emission
levels, chlorofluorocarbon propellants, hearing aids, menstrual tampons, chlorofluorocarbons or other ozone depleting
substances, latex condoms, and devices containing natural rubber.
78 21 CFR 820.120
79 FFDCA §520; 21 CFR 820
80 FDA, Medical Devices: 1. The Quality System Regulation, June 18, 2009, http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/
MedicalDeviceQualitySystemsManual/ucm122391.htm.
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Postmarketing Surveillance
The 2011 IOM report states that because “it is not possible to create a premarket review process
that could completely ensure the safety of all devices before they enter the market, a strong
surveillance system that monitors the safety of medical devices is essential. The identification of
problems associated with a medical device can be an opportunity for various corrective
actions.”81 Such actions might include changing the device labeling and instructions for use,
improving user training, or removal of the device from the market if appropriate. While the term
postmarketing surveillance refers to a wide range of programs, the term postmarket surveillance
refers to a specific activity defined in law.82
Postmarket Surveillance
For certain devices introduced into interstate commerce after January 1, 1991, manufacturers
must conduct postmarket surveillance studies, once their device is approved or cleared for
marketing, in order to gather safety and efficacy data. This requirement applies to devices that
• are permanent implants, the failure of which may cause serious adverse health
consequences or death;
• are intended for use in supporting or sustaining human life; or
• present a potential serious risk to human health.
FDA may require postmarket surveillance for other devices if deemed necessary to protect the
public health. The primary objective of postmarket surveillance is to study the performance of the
device after clearance or approval as it is used in the population for which it is intended—and to
discover cases of device failure and its attendant impact on the patient. Manufacturers may
receive notification that their device is subject to postmarket surveillance when FDA files (i.e.,
accepts) the submission, and again when a final decision is made. If notified, manufacturers must
submit a plan for postmarket surveillance to FDA for approval within 30 days of introducing their
device into interstate commerce. MDUFA authorized the appropriation of $25 million per year for
Postmarket Studies and Surveillance.83
Adverse Event Reporting
The Safe Medical Devices Act of 1990 (SMDA, P.L. 101-629) required FDA to establish a
system for monitoring and tracking serious adverse events that resulted from the use or misuse of
medical devices.84 The Medical Device Reporting (MDR) regulation is the mechanism that FDA
and manufacturers use to identify and monitor significant adverse events involving medical
devices, so that problems are detected and corrected in a timely manner. 85
81 IOM, Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years, Washington, DC,
July 2011, p. 99.
82 FFDCA §522.
83 21 USC 355 note
84 FFDCA §519(a)
85 The searchable MDR database for devices is publically accessible at http://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfmdr/search.CFM.
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Device manufacturers are required to report to FDA (1) within 30 calendar days of acquiring
information that reasonably suggests one of their devices may have caused or contributed to a
death, serious injury, or malfunction and (2) within 5 working days if an event requires action
other than routine maintenance or service to prevent a public health issue.86 User facilities, such
as hospitals and nursing homes, are also required to report deaths to both the manufacturer, if
known, and FDA within 10 working days.87 User facilities must report serious injuries to the
manufacturers (or FDA if the manufacturer is unknown) within 10 working days.88 User facilities
must also submit annual reports to FDA of all adverse event reports sent to manufacturers or FDA
in the past year.89
In August 2009, FDA published notice of a proposed rule, and a related draft guidance document,
that would require manufacturers to submit MDRs to the agency in an electronic format.90
According to FDA, the proposed regulatory changes would provide the agency with a more
efficient data entry process that would allow for timely access to medical device adverse event
information and identification of emerging public health issues. The device industry requested a
longer timeframe to implement the changes.
An October 2009 HHS Office of Inspector General report raised a number of questions about
adverse event reporting for medical devices.91 The report found that CDRH does not consistently
use adverse event reporting and made several recommendations about how it could better do so.
Medical Device Tracking
Manufacturers are required to track certain devices from their manufacture through the
distribution chain when they receive an order from FDA to implement a tracking system for a
certain type of device.92 The purpose of device tracking is to ensure that manufacturers of these
devices can locate them quickly once in commercial distribution if needed to facilitate
notifications and recalls in the case of serious risks to health presented by the devices. FDA may
issue a tracking order for any Class II or Class III device:
• the failure of which would be reasonably likely to have serious adverse health
consequences;
• which is intended to be implanted in the human body for more than one year; or
86 21 CFR 803.10(c)(1) and 803.10(c)(2)
87 21 CFR 803.10(a)(1)(i).
88 21 CFR 803.10(a)(1)(ii).
89 21 CFR 803.10(a)(2) and 803.33.
90 FDA, “Proposed Rule, Medical Device Reporting: Electronic Submission Requirements,” 74 Federal Register
42203-42217, August 21, 2009; and FDA, “Draft Guidance for Industry, User Facilities, and Food and Drug
Administration Staff; eMDR—Electronic Medical Device Reporting; Availability,” 74 Federal Register Page 42310,
August 21, 2009.
91 Daniel R. Levinson, Adverse Event Reporting for Medical Devices, HHS Office of Inspector General, OEI-01-08-
00110, October 2009, http://oig.hhs.gov/oei/reports/oei-01-08-00110.pdf.
92 FDA, Medical Device Tracking, May 13, 2009, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
PostmarketRequirements/MedicalDeviceTracking/default.htm#link_2.
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• which is intended to be a life sustaining or life supporting device used outside a
device user facility.93
FDA has issued orders to track 13 implantable devices (including silicone gel-filled breast
implants, various joint prostheses, implantable pacemakers, implantable defibrillator, mechanical
heart valves, and implantable infusion pumps) and four other devices that are used outside a
device user facility.94
The Sentinel Initiative
Section 905 of FDAAA mandated that FDA create an active postmarket risk identification
system.95 Although the FDAAA language is focused on monitoring drugs, FDA is using its
general authority to monitor all FDA-regulated products, including medical devices, after they
have reached the market.96 FDA launched the Sentinel Initiative in May 2008; once completed, it
will be called the Sentinel System. FDAAA set goals that the new system must be able to access
data on 25 million people by July 2010, a goal which FDA has met, and 100 million people by
July 2012.97 As of January 2011 FDA has the capacity to access data from the electronic health
records of more than 60 million people.98
FDA is collaborating with institutions throughout the United States, including academic medical
centers, healthcare systems and health insurance companies, who act as data partners in the
system. Additional collaborators will include patient and healthcare professional advocacy
groups, academic institutions and the medical products industry. As an example of data applicable
to medical devices, “one Sentinel-related project identified, described, and evaluated potential US
orthopedic-implant registries that could participate in the creation of a national network of such
registries as part of the Sentinel Initiative. Data related to medical devices include rates of
selected outcomes (for example, myocardial infarction and stroke), rates of infection, and rates of
implant revision and reintervention.”99 According to FDA, the Sentinel Initiative aims to develop
and implement a proactive system that will complement existing systems that the agency has in
place to track reports of adverse events linked to the use of its regulated products.100
93 21 CFR 821
94 A device user facility means a hospital, ambulatory surgical facility, nursing home, or outpatient treatment facility
which is not a physician’s office. A current list of the devices for which tracking is required can be found at
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/MedicalDeviceTracking/
default.htm#link_2.
95 FFDCA §505(k); 21 USC 355
96 FFDCA §1003(b)(2)(c)
97 U.S. Food and Drug Administration, The Sentinel Initiative: Access to Electronic Healthcare Data for More Than 25
Million Lives, July 2010, http://www.fda.gov/downloads/Safety/FDAsSentinelInitiative/UCM233360.pdf.
98 Rachel E. Behrman, Joshua S. Benner, and Jeffrey S. Brown, et al., “Developing the Sentinel System—A National
Resource for Evidence Development,” The New England Journal of Medicine, vol. 364, no. 6 (February 10, 2011), pp.
498-499. The Sentinel Initiative is focused on electronic claims data held by health plans. Importantly, the plans retain
control over the patient-level data within their own data firewalls and provide only aggregated information to FDA.
99 IOM, Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years, Washington, DC,
July 2011, p. 106.
100 Information on the current status of the Sentinel Initiative is available at http://www.fda.gov/Safety/
FDAsSentinelInitiative/default.htm.
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Unique Device Identification
A provision in FDAAA requires the HHS Secretary to promulgate regulations establishing a
unique device identification (UDI) system.101 When implemented, this new system will require
• the label of a device to bear a unique identifier, unless an alternative location is
specified by FDA or unless an exception is made for a particular device or group
of devices;
• the unique identifier to be able to identify the device through distribution and
use; and
• the unique identifier to include the lot or serial number if specified by FDA.
According to FDA, “incorporation of UDI into various health-related databases will greatly
facilitate many important public health-related activities including: reducing medical errors;
reporting and assessing device-related adverse events and product problems; tracking of recalls;
assessing patient-centered outcomes and the risk/benefit profile of medical devices in large
segments of the U.S. population; and, providing an easily accessible source of device
identification information to patients and health care professionals.”102
CDRH indicated in its FY2010 Strategic Priorities that the UDI system will be implemented by
September 30, 2013.103 UDI will be implemented in three phases: Class III devices will need to
be in compliance within one year after the final rule is published, Class II at three years and Class
I at five years after the final rule.104 FDA has held a number of public meetings and workshops
with stakeholders to discuss the adoption, implementation, and use of a UDI system. The agency
has posted on its website information about these meetings as well as a number of reports on the
use of UDI for medical devices.105
FDA has been working with the Global Harmonization Task Force (GHTF) to foster international
harmonization in the regulation of medical devices through the development of non-binding
guidance documents.106 The GHTF is a voluntary international group of representatives from
medical device regulatory authorities and trade associations from Europe, the United States,
Canada, Japan and Australia. In September 2011 the GHTF published its final document on UDI
for medical devices.107
101 FFDCA §519(f); 21 USC 360i
102 FDA, “Unique Device Identification for Postmarket Surveillance and Enforcement; Public Workshop,” 76 Federal
Register 43691-43693, July 21, 2011.
103 FDA, Center for Devices and Radiological Health, CDRH FY 2010 Strategic Priorities, p. 6, http://www.fda.gov/
downloads/AboutFDA/CentersOffices/CDRH/CDRHVisionandMission/UCM197648.pdf.
104 Alaina Bush, “CER, Safety uses eyed as part of FDA device identification rule,” Inside Health Reform, vol. 3, no.
39 (September 22, 2011).
105 Meeting information, reports and current status of the UDI system can be found at http://www.fda.gov/
MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm
106 GHTF website is at http://www.ghtf.org/.
107 GHTF SC UDI Ad Hoc Working Group, Unique Device Identification (UDI) System for Medical Devices, Global
Harmonization Task Force, GHTF/AHWG-UDI/N2R3:2011, September 16, 2011, http://www.ghtf.org/documents/
ahwg/AHWG-UDI-N2R3.pdf.
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Compliance and Enforcement
Compliance requirements apply to both the premarket approval process and postmarket
surveillance. When a problem arises with a product regulated by FDA, the agency can take a
number of actions to protect the public health. Initially, the agency tries to work with the
manufacturer to correct the problem on a voluntary basis. If that fails, legal remedies may be
taken, such as: asking the manufacturer to recall a product, having federal marshals seize
products, or detaining imports at the port of entry until problems are corrected. If warranted, FDA
can ask the courts to issue injunctions or prosecute individual company officers that deliberately
violate the law. When warranted, criminal penalties, including prison sentences, may be sought.
Section 516 of the FFDCA gives FDA the authority to ban devices that present substantial
deception or unreasonable and substantial risk of illness or injury. Section 518 enables FDA to
require manufacturers or other appropriate individuals to notify all health professionals who
prescribe or use the device and any other person (including manufacturers, importers, distributors,
retailers, and device users) of any health risks resulting from the use of a violative device, so that
these risks may be reduced or eliminated. This section also gives consumers a procedure for
economic redress when they have been sold defective medical devices that present unreasonable
risks. Section 519 of the act authorized FDA to promulgate regulations requiring manufacturers,
importers, and distributors of devices to maintain records and reports to assure that devices are
not adulterated or misbranded. Section 520(e) authorizes FDA to restrict the sale, distribution, or
use of a device if there cannot otherwise be reasonable assurance of its safety and effectiveness. A
restricted device can only be sold on oral or written authorization by a licensed practitioner or
under conditions specified by regulation.
Inspection
Each FDA center has an Office of Compliance (OC) that ensures compliance with regulations
while pre- or postmarket studies are being undertaken, with manufacturing requirements, and
with labeling requirements. The objectives of CDRH’s OC’s Bioresearch Monitoring (BIMO)
program are to ensure the quality and integrity of data and information submitted in support of
IDE, PMA, and 510(k) submissions and to ensure that human subjects taking part in
investigations are protected from undue hazard or risk. This is achieved through audits of clinical
data contained in PMAs prior to approval, data audits of IDE and 510(k) submissions, inspections
of IRBs and nonclinical laboratories, and enforcement of the prohibitions against promotion,
marketing, or commercialization of investigational devices. Any establishment where devices are
manufactured, processed, packed, installed, used, or implanted or where records of results from
use of devices are kept, can be subject to inspection. (See Table 2.)
Table 2. CDRH, FDA Foreign and Domestic Inspections, FY2004–FY2010
FY
2004 2005 2006 2007 2008 2009 2010
Number of
2,936 2,694 2,691 2,495 2,353 2,550 3,174
Inspections
Source: FDA Center for Devices and Radiological Health, Office of Compliance, Division of Risk Management
Operations based on Center Ad Hoc Reporting System inspection data.
The OC also reviews the quality system design and manufacturing information in the PMA
submission to determine whether the manufacturer has described the processes in sufficient detail
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and to make a preliminary determination of whether the manufacturer meets the QSR. If the
manufacturer has provided an adequate description of the design and manufacturing process, a
preapproval inspection can be initiated. Inspection is to include an assessment of the
manufacturer’s capability to design and manufacture the device as claimed in the PMA and
confirm that the quality system is in compliance with the QSR. Postapproval inspections can be
conducted within 8 to 12 months of approval of the PMA submission. The inspection is to
primarily focus on any changes that may have been made in the device design, manufacturing
process, or quality systems.
The compliance offices work closely with the Office of Regulatory Affairs (ORA),108 which
operates in the field to regulate almost 124,000 business establishments that annually produce,
warehouse, import and transport $1 trillion worth of medical products. Consumer safety officers
(CSOs) and inspectors typically have conducted about 22,000 domestic and foreign inspections a
year to ensure that regulated products meet the agency’s standards. CSOs also monitor clinical
trials. Scientists in ORA’s 13 laboratories typically have analyzed more than 41,000 product
samples each year to determine their adherence to FDA’s standards.
Warning Letter
A warning letter is a written communication from FDA notifying a responsible individual,
manufacturer, or facility that the agency considers one or more products, practices, processes, or
other activities to be in violation of the laws that FDA enforces. The warning letter informs the
recipient that failure to take appropriate and prompt action to correct and prevent any future
repeat of the violations could result in an administrative or regulatory action. Although serious
noncompliance is often a catalyst for issuance of a warning letter, the warning letter is informal
and advisory.109 (See Table 3.)
Table 3. CDRH Warning Letters Issued, FY2000–FY2010
FY 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
Number
528 498 285 205 198 182 154 155 152 136 204
of Letters
Source: FDA Center for Devices and Radiological Health, Office of Compliance, Division of Risk Management
Operations based on Office of Regulatory Affairs Case Management System warning letter data.
Product Recall
A recall is a method of removing or correcting products that FDA considers are in violation of the
law.110 Medical device recalls are usually conducted voluntarily by the manufacturer after
108 See ORA at http://www.fda.gov/AboutFDA/CentersOffices/ORA/default.htm.
109 Warning letters are publically available on FDA’s website at http://www.fda.gov/ICECI/EnforcementActions/
WarningLetters/default.htm.
110 Recall does not include market withdrawal or a stock recovery. A market withdrawal is a firm’s removal or
correction of a distributed product for a minor violation that does not violate the law and would not be subject to legal
action by FDA (e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc.). Stock recovery
involves correction of a problem before product is shipped (i.e., is still in the manufacturer’s control).
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negotiation with FDA.111 Manufacturers (including refurbishers and reconditioners) and importers
are required to report to FDA any correction or removal of a medical device that is undertaken to
reduce a health risk posed by the device.112 A recall may be a total market withdrawal or may be
of a portion of product (such as a single lot). In rare instances, where the manufacturer or
importer fails to voluntarily recall a device that is a risk to health, FDA may issue a recall order to
the manufacturer.113
When a recall is initiated, FDA performs an evaluation of the health hazard presented taking into
account the following factors, among others:
• Whether any disease or injuries have occurred from the use of the product;
• Whether any existing conditions could contribute to a clinical situation that could
expose humans or animals to a health hazard;
• Assessment of hazard to various populations (e.g., children, surgical patients,
pets, livestock) who would be exposed to the product;
• Assessment of the degree of seriousness of the health hazard to which the
populations at risk would be exposed;
• Assessment of the likelihood of occurrence of the hazard;
• Assessment of the consequences (immediate or long-range) of the hazard.
Following the health hazard assessment, FDA assigns the recall a classification according to the
relative degree of health hazard. Class I recalls are the most serious, reserved for situations where
there is a reasonable probability that the use of, or exposure to, a product will cause serious
adverse health consequences or death. Class II recalls are for situations where the use of, or
exposure to, a product may cause temporary or medically reversible adverse health consequences
or where the probability of serious adverse health consequences is remote. In a Class III recall
situation, the use of, or exposure to, a product is not likely to cause adverse health consequences.
(See Table 4.) In addition to a warning letter or recall, FDA may issue a public notification or
safety alert (e.g., “Dear Doctor” letter), to warn healthcare providers and consumers of the risk of
the device.114
Table 4. CDRH Class I, II, and III Product Recalls, FY2004–FY2010
FY 2004 2005 2006 2007 2008 2009 2010
Class
I 36 77 76 45 131 219 334
Class
II 1,235 1,351 1,252 1,102 2,178 2,222 2,208
Class
III 219 170 222 132 163 194 92
Source: FDA Center for Devices and Radiological Health, Office of Compliance, Division of Risk Management
Operations based on Center Ad Hoc Reporting System recall data.
111 21 CFR 7
112 21 CFR 806.
113 21 CFR 810. See out-of-print CRS Report RL34167, The FDA’s Authority to Recall Products, by Vanessa K.
Burrows (available from the author upon request).
114 The main page for recalls, market withdrawals, and safety alerts for all FDA-regulated products is
http://www.fda.gov/opacom/7alerts.html.
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Appendix A. History of Laws Governing Medical
Device Regulation
The Federal Food, Drug and Cosmetics Act of 1938
The first general federal food and drug law, the Food and Drugs Act of 1906, did not contain any
provisions to regulate medical device safety or claims made regarding such devices. Strong
support for reform developed during the 1930s due to “false therapeutic claims for medical
devices [that] were being presented to the public through radio and newspaper advertising.”115
Medical devices came under federal scrutiny when Congress passed the Federal Food, Drug and
Cosmetic Act (FFDCA) of 1938 (P.L. 75-717). The regulatory authority provided to FDA by the
1938 law was “limited to action after a medical device has been offered for introduction into
interstate commerce” and only when the device was deemed to be “adulterated or misbranded.”116
Most of the legitimate devices on the market at the time the 1938 Act became law “were
relatively simple items which applied basic science concepts such that experts using them could
readily recognize whether the device was functioning properly; the major concern with respect to
these devices was assuring truthful labeling.”117 During the first 20 years following enactment of
the 1938 law, FDA’s activity with respect to medical devices involved protecting the American
public from fraudulent devices; FDA began to turn its attention to the hazards from legitimate
devices around 1960.118
The post-war revolution in biomedical technology had resulted in the introduction of a wide
variety of sophisticated devices. New developments in the electronic, plastic, metallurgy, and
ceramics industries, coupled with progress in design engineering, led to invention of the
heart pacemaker, the kidney dialysis machine, defibrillators, cardiac and renal catheters,
surgical implants, artificial vessels and heart valves, intensive care monitoring units, and a
wide spectrum of other diagnostic and therapeutic devices. Although many lives have been
saved or improved by the new discoveries, the potential for harm to consumers has been
heightened by the critical medical conditions in which sophisticated modern devices are used
and by the complicated technology involved in their manufacture and use. In the search to
expand medical knowledge, new experimental approaches have sometimes been tried
without adequate premarket clinical testing, quality control in materials selected, or patient
consent.119
The Dalkon Shield, a contraceptive device introduced in November 1970, is “an example of a
legitimate device which was marketed without adequate premarket testing.”120 Other examples
115 U.S. Congress, House Committee on Interstate and Foreign Commerce, Medical Device Amendments of 1976, to
accompany H.R. 11124, 94th Cong., 2nd sess., February 29, 1976, H. Rept. 94-853, p. 6.
116 Ibid. “A device is adulterated if it includes any filthy, putrid, or decomposed substance, or if it is prepared, packed,
or held under unsanitary conditions. A device is misbranded if its labeling is false or misleading; unless it identifies the
manufacturer, packer, or distributor and quantity of contents; if required labeling statements are not conspicuous; if it
fails to bear adequate directions for use or adequate warnings; or if it is dangerous to health when used as indicated.”
117 Ibid.
118 Ibid., p. 7.
119 Ibid., p. 7-8.
120 Ibid., p. 8. By 1975, the Dalkon Shield had been linked to at least 16 deaths and 25 miscarriages, numerous cases of
(continued...)
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include defective cardiac pacemakers and intraocular lenses which, following implantation,
caused unusual eye infections resulting in serious vision impairment or the need for removal of
the eye.
Congress amended the FFDCA in 1962 to require FDA approval of a new drug application prior
to marketing and to require that a new drug be shown to be effective as well as safe. Following
these changes, FDA began “to impose rigorous premarket approval of some products that today
would be deemed devices.” Court decisions in the late 1960s upheld FDA’s authority to regulate
some medical devices as drugs due in part to the overlapping definitions of drug and device in the
1938 law. FDA classified a number of devices as drugs (contact lenses, injectable silicone,
pregnancy-test kits, bone cement), and only such devices were subject to premarket review (prior
to 1976). However the approach of classifying devices as a drug was unsuccessful in other court
decisions and the need for more comprehensive authority to regulate devices was recognized by
the Kennedy, Johnson and Nixon administrations.121
The Medical Device Amendments of 1976
The Medical Device Amendments of 1976 (MDA; P.L. 94-295) was the first major legislation
passed to address the review of medical devices. The MDA provided a definition for the term
device.122 It established a number of requirements referred to as general controls that applied to
all devices.123 Examples include provisions on adulteration and misbranding, prohibitions on false
or misleading advertising, and a requirement to register all medical device manufacturers with
FDA. One such provision required manufacturers to notify FDA 90 days prior to the marketing of
any new device; if the agency failed to act, marketing could begin. Because this provision is
outlined in section 510(k) of the FFDCA, it is often referred to as a “510(k) notification.”
The MDA directed FDA to classify, into one of three classes, all medical devices that were on the
market at the time of enactment; these are the preamendment devices.124 Congress provided
(...continued)
pelvic perforation and pelvic infection, removal of the IUD for medical reasons, and pregnancies due to IUD failure. As
of February 1976, more than 500 lawsuits seeking compensatory and punitive damages totaling more than $400 million
were pending against the manufacturer of the Dalkon Shield. IOM, Medical Devices and the Public’s Health: The FDA
510(k) Clearance Process at 35 Years, Washington, DC, July 2011, p. 172, http://www.iom.edu/Reports/2011/Medical-
Devices-and-the-Publics-Health-The-FDA-510k-Clearance-Process-at-35-Years.aspx.
121 U.S. Congress, House Committee on Interstate and Foreign Commerce, Medical Device Amendments of 1976, to
accompany H.R. 11124, 94th Cong., 2nd sess., February 29, 1976, H. Rept. 94-853, p. 8-9.
122 An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related
article, including any component, part, or accessory, which is (1) recognized in the official National Formulary, or the
United States Pharmacopeia, or any supplement to them; (2) intended for use in the diagnosis of disease or other
conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals; or (3) intended to
affect the structure or any function of the body of man or other animals, and which does not achieve any of its principal
intended purposes through chemical action within or on the body of man or other animals and which is not dependent
upon being metabolized for the achievement of its primary intended purposes. The definition was changed in 1992
from “any of its principal intended purposes” to “its primary intended purposes.” Current definition at FFDCA §201(h),
(21 U.S.C. 321).
123 The law has since been amended to exempt many (Class I) products from some general controls or to limit the
application of general controls to subsets of (Class II or Class III) products that pose higher risks. IOM, Medical
Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years, Washington, DC, July 2011, p. 175.
124 Preamendment devices were presumed to be marketable. They did not undergo premarket review and could be
legally marketed unless FDA required their removal. After classifying the preamendment devices, FDA used them as
(continued...)
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definitions for the three classes—Class I, Class II, Class III—based on the risks to patients posed
by the devices. In contrast to the approach taken with pharmaceuticals (all, except generic agents,
undergo rigorous premarket review and approval), Congress limited premarket approval to only a
small number of devices. “Only the highest-risk category [Class III] would require agency review
and approval as a precondition for commercial sale and routine medical use. The other two
categories would be subject not to a rigorous review but merely a requirement [510(k)] that the
manufacturer of a device notify FDA, at least 90 days before commencing marketing, of its intent
to distribute the product commercially.”125 For Class I devices, no additional review was needed
once the status of Class I was confirmed; general controls were considered to be sufficient to
protect public health. For Class II devices, limited supplemental review would be needed to verify
conformity with performance standards if such standards had been established by the agency.126
Under MDA, all devices coming to market after enactment were automatically placed in Class III
until reclassified; these are the postamendment devices. As stated above, Class III medical
devices receive more intense scrutiny and require an application for premarket approval (PMA)
before the device can be marketed. However, the MDA allowed for the reclassification of a
device from one class to another. According to a 2011 IOM report on medical devices:
The classification and reclassification process did not include any evaluation of the safety or
effectiveness of the device types being categorized. Once a device type was assigned to Class
III, the FDA was directed to promulgate a regulation calling for manufacturers of devices of
that type to submit a [PMA] application. The agency would then (and only then) undertake a
review of the safety and effectiveness of the devices. For device types placed into Class I or
Class II, there was no mechanism for the systematic review of safety and effectiveness.
Congress envisioned instead that the agency would use its postmarketing tools to identify
and address issues of lack of safety or lack of effectiveness case by case. Thus,
preamendment devices in Class I and II were never subjected to a comprehensive FDA
evaluation for safety or effectiveness. The classification process was not completed until
1988.127
For postamendment devices, which were automatically placed into Class III, there were two
important exceptions:
The primary exception involved a postamendment device that was substantially equivalent to
another device of the same type that either as a preamendment device that had not been
classified into any class or was not a preamendment device but had already been classified
into Class I or Class II. The FDA permitted manufacturers of postamendment devices to
demonstrate substantial equivalence to a preamendment device in Class I or II as part of the
510(k) submission. An alternative exception provided that the postamendment device would
not be in Class III if the FDA, in response to a petition, classified it into Class I or Class II.128
The MDA did not provide a definition for the term substantially equivalent. The MDA also did
not itemize the required contents of a 510(k). Such a notification “need only set forth its proposed
(...continued)
the first cadre of “predicate” devices in order to demonstrate substantial equivalence.
125 Ibid., p. 24.
126 Ibid., p. 177.
127 Ibid., p. 25.
128 Ibid., p. 179.
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intended use or indications for use, the device to which substantial equivalence is claimed, and
evidence demonstrating that equivalence.”129
The Safe Medical Devices Act of 1990
The Safe Medical Devices Act of 1990 (SMDA; P.L. 101-629) made a number of changes to the
law such as providing a definition for the term substantial equivalence and revising the definition
for Class II. FDA had not promulgated performance standards for most Class II devices. The new
law authorized the use of alternative restrictions, called special controls, at the agency’s discretion
and simplified the process of establishing performance standards for Class II devices. Examples
of special controls include special labeling requirements, mandatory performance standards,
patient registries and postmarket surveillance.
FDA also had experienced difficulty in promulgating regulations needed to require submission of
PMA applications for Class III devices. SMDA authorized FDA to reconsider all the
preamendment devices that had been placed in Class III and reclassify some of these devices into
Class I or Class II.130 The purpose was “to reduce the number of device types that needed PMA
review.”131 For those devices remaining in Class III, the agency was directed to establish a
schedule for promulgation of regulations calling for PMAs of devices that still used the 510(k)
notification as an entry to the marketplace.
Under SMDA, FDA must issue a response to a
510(k) submission before marketing of a new
U.S. Supreme Court 1996 Opinion
device can begin. SMDA allowed for the
Medtronic v. Lohr
evaluation of safety and effectiveness data in
“Substantial equivalence determinations provide little
510(k) notifications, but only in certain
protection to the public. These determinations simply
situations. These were limited to cases in
compare a post-1976 device to a pre-1976 device to
which a new device offered different
ascertain whether the latter is no more dangerous and
no less effective than the earlier device. If the earlier
technologic characteristics from the already
device poses a severe risk or is ineffective, then the
marketed premendment or postamendment
latter device may also be risky or ineffective.”
(predicate) device.132 “Because the assessment
Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).
of substantial equivalence generally did not
require evidence of safety or effectiveness of a device and because a preamendment device to
which equivalence was established was not itself reviewed for safety or effectiveness, the FDA
made clear from the outset that clearance of a 510(k) notification was not a determination that the
cleared device was safe or effective. That position was reiterated by the agency numerous times.
The US Supreme Court accepted this interpretation in a 1996 opinion.”133
SMDA established postmarket requirements for medical devices. SMDA required facilities that
use medical devices to report to FDA any incident that suggested that a medical device could
129 Ibid. p. 180.
130 FFDCA §515(i).
131 IOM, Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years, Washington, DC,
July 2011, p. 205.
132 FFDCA §513(i).
133 IOM, Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years, Washington, DC,
July 2011, p. 28.
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have caused or contributed to the death, serious illness, or injury of a patient. Manufacturers of
certain permanently implanted devices were required to establish methods for tracking the
patients who received them and to conduct postmarket surveillance to identify adverse events.
The act authorized FDA to carry out certain enforcement actions, such as device product recalls,
for products that did not comply with the law.
The Food and Drug Administration Modernization Act of 1997
The Food and Drug Administration Modernization Act of 1997 (FDAMA; P.L. 105-115)
mandated wide-ranging reforms in the regulation of foods, drugs and medical devices by FDA. In
general, provisions involving medical devices “were designed to reduce FDA’s workload and
permit concentration of resources on devices that presented greater potential for harm” and “to
limit the FDA’s discretion and authority in regulating the device industry” in order to “accelerate
the pace of technology transfer.”134
FDAMA eliminated the 510(k) notification requirement for most Class I devices and some Class
II devices. It authorized the creation of a third-party review system of 510(k) submissions for
Class I and most Class II devices that still required 510(k) review. It allowed certain new devices
(those not substantially equivalent to another device and automatically placed in Class III) to be
evaluated for immediate placement in Class I or Class II. This process, called the de novo 510(k),
avoids PMA review, must be completed in 60 days, and may be requested by the sponsor.
For substantial equivalence determinations in which the new device has a different technological
characteristic, FDAMA requires that FDA “consider the least burdensome means of
demonstrating substantial equivalence and request information accordingly.”135 For a medical
device using an important breakthrough technology, or which does not have an approved
alternative device, priority review of the PMA must be provided by FDA.136
FDAMA limited the use of some postmarket controls (device tracking and postmarket
surveillance) to Class II and Class III devices, eased reporting requirements of adverse events for
device user facilities, eliminated mandatory reporting of adverse events by medical device
distributors, and directed FDA to establish a sentinel reporting system to collect information on
deaths and serious injuries or illnesses associated with the use of a medical device.137
User Fee Acts and the FDA Amendments Act of 2007
The Medical Device User Fee and Modernization Act of 2002 (MDUFMA; P.L. 107-250)
established a user fee program for premarket reviews of 510(k) submissions and PMA
applications; user fees may not be used for other FDA or CDRH activities. MDUFMA also made
targeted changes that would reduce regulatory burdens and agency workload, such as allowing
establishment inspections to be conducted by accredited persons (third parties). MDUFMA was
amended and clarified by two laws: the Medical Device Technical Corrections Act of 2004
134 Ibid., p. 213.
135 FFDCA §513(i)(1)(D).
136 FFDCA §515(d)(5).
137 FFDCA §519 and §522. A device user facility means a hospital, ambulatory surgical facility, nursing home, or
outpatient treatment facility which is not a physician’s office.
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(MDTCA, P.L. 108-214), and the Medical Device User Fee Stabilization Act of 2005
(MDUFSA, P.L. 109-43), and had its user fee provisions reauthorized by the Medical Device
User Fee Act of 2007 (MDUFA; Title II of FDAAA, see below).
The Food and Drug Administration Amendments Act of 2007 (FDAAA; P.L. 110-85) amended
the FFDCA and the Public Health Service Act to reauthorize several expiring programs (including
the medical device user fee act) and to make agency-wide changes, several of which have
implications for the regulation of medical devices.138 FDAAA created incentives as well as
reporting and safety requirements for manufacturers of medical devices for children; required that
certain clinical trials for medical devices and some other products be publicly registered and have
their results posted;139 created requirements to reduce conflicts of interest in advisory committees
for medical devices and other products;140 and made certain other amendments to the regulation
of devices.
138 See CRS Report RL34465, FDA Amendments Act of 2007 (P.L. 110-85), by Erin D. Williams and Susan Thaul.
139 See the Clinical Trials Databases section of CRS Report RL34465, FDA Amendments Act of 2007 (P.L. 110-85), by
Erin D. Williams and Susan Thaul.
140 FDA uses advisory committees to gain independent advice from outside experts. See CRS Report RS22691, FDA
Advisory Committee Conflict of Interest, by Erin D. Williams.
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Appendix B. Acronyms Used in this Report
BIMO
Bioresearch Monitoring
CBER
Center for Biologics Evaluation and Research
CDRH
Center for Devices and Radiological Health
CFR
Code of Federal Regulations
CSOs
Consumer safety officers
FDA
Food and Drug Administration
FDAAA
Food and Drug Administration Amendments Act of 2007
FDAMA
Food and Drug Administration Modernization Act of 1997
FFDCA
Federal Food, Drug and Cosmetic Act
GAO
General Accountability Office
GGP
Good Guidance Practices
GHTF
Global Harmonization Task Force
GMP
Good manufacturing practices
HHS
Health and Human Services
IDE
Investigational Device Exemption
IOM
Institute of Medicine
IRB
Institutional review board
IVD
In Vitro Diagnostic
MDA
Medical Device Amendments of 1976
MDR
Medical Device Reporting
MDTCA
Medical Device Technical Corrections Act of 2004
MDUFA
Medical Device User Fee Act of 2007
MDUFMA
Medical Device User Fee and Modernization Act of 2002
MDUFSA
Medical Device User Fee Stabilization Act of 2005
NSE
Not substantially equivalent
OC
Office of Compliance
ORA
Office of Regulatory Affairs
PMA
Premarket Approval
QSR
Quality Systems Regulation
SMDA
Safe Medical Devices Act of 1990
UDI
Unique device identification
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Author Contact Information
Judith A. Johnson
Specialist in Biomedical Policy
jajohnson@crs.loc.gov, 7-7077
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