Summary

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.

Introduction

Device Classification

Examples

Safety / Effectiveness Controls

Required Submission

Class I

elastic bandages, examination gloves, and hand-held surgical instruments

General Controls

Class II

Class III

General Controls

-510(k) clearance

FDASIA changed the process for the reclassification of a device from rulemaking to an administrative order.³⁹ Early in 2013, FDA published proposed orders in the Federal Register to reclassify some of these devices.⁴⁰ One such proposed order, published January 18, 2013, would require current and future manufacturers of metal-on-metal hip implants to submit a PMA, including clinical data demonstrating safety and effectiveness, within 90 days of publication of the final order.⁴¹ Comments on this proposed order must be submitted to FDA by April 18, 2013.

For certain new devices FDA may, in response to a request for a de novo device classification, classify the new device without first issuing a determination that it is not substantially equivalent to an existing device.⁶⁶ This classification request may be declined if there exists a legally marketed device on which to base a substantial equivalence review, or if the new device is not a low-moderate risk device or general controls would be inadequate to control risks and special controls cannot be developed.

Assessments of the 510(k) Process

As mentioned earlier, several reports have examined aspects of the FDA device review process.⁶⁷ FDAAA (2007) required GAO to study and report on the appropriate use of the 510(k) process "to determine whether a new device is as safe and effective as a classified device."⁶⁸ The report, released in January 2009, found that a number of Class III devices—including device types that are implantable, life sustaining, or posing a significant risk to the health, safety or welfare of a patient—were cleared for the U.S. market through FDA's less stringent 510(k) review process.⁶⁹ GAO recommended that "FDA expeditiously take steps to issue regulations for Class III device types currently allowed to enter the market via the 510(k) process by requiring PMAs or reclassifying them to a lower class." ⁷⁰

In December 2008 an orthopedic device made by ReGen, a New Jersey company, was cleared for marketing via the 510(k) process. Acting FDA Commissioner, Joshua Sharfstein, initiated in April 2009 an internal review of the decision to clear the ReGen Menaflex device.⁷¹ In September 2009, FDA released a preliminary report on the review of ReGen Menaflex device.⁷² The report provides a list of 22 instances in which the agency did not follow established processes, procedures or practices.⁷³ The report provides a possible reason for this, noting "the presence of widespread internal disagreement and confusion about the legal standard for 510(k) review."⁷⁴ Acting Commissioner Sharfstein said that the report made "a series of recommendations, all of which will be adopted."⁷⁵

In September 2009, FDA announced that it had requested an independent evaluation of the 510(k) process by IOM.⁷⁶ The agency also stated it would convene its own internal comprehensive assessment of the 510(k) process by forming two FDA staff working groups. One group would review the 510(k) program and make recommendations to enhance the decision-making process. The second group would review how the agency incorporates new science into its decision making and make recommendations on incorporating new science while maintaining predictability in the process for industry. During the process of developing the two internal reports, FDA sought public input via two public meetings, three town hall meetings, three public dockets, and many smaller meetings with various stakeholder groups.⁷⁷

FDA released the two final reports of the agency's internal review in August 2010.⁷⁸ The reports contained a total of 55 recommendations; the agency again sought public comment on the two reports and the recommendations. In January 2011, FDA released its "Plan of Action," based on some of the recommendations in the August 2010 internal review reports.⁷⁹ Further information about FDA's "Plan of Action" and list of accomplishments for its implementation are provided on the agency's website.⁸⁰

In July 2011 IOM released a report on the 510(k) process.⁸¹ The IOM Committee recommended that the current 510(k) process be "replaced with an integrated premarket and postmarket regulatory framework that effectively provides a reasonable assurance of safety and effectiveness throughout the device life cycle."⁸²

A PMA is "the most stringent type of device marketing application required by FDA" for new and/or high-risk devices.⁸³ PMA approval is based on a determination by FDA that the application contains sufficient valid scientific evidence to provide reasonable assurance that the device is safe and effective for its intended use(s).⁸⁴ In contrast to a 510(k), PMAs generally require some clinical data, or studies from the medical literature (sometimes called a "paper PMA"), prior to gaining approval.⁸⁵

All clinical evaluations of investigational devices (unless exempt) must have an investigational device exemption (IDE) before the clinical study is initiated.⁸⁶ An IDE allows an 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.⁸⁷ 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.⁸⁸ All clinical studies must also receive prior approval by an institutional review board (IRB).⁸⁹

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).⁹⁰ 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.⁹¹ They are comprised of scientific, medical, and statistical experts, and industry and consumer representatives. An advisory committee meeting allows interested persons to present information and views at a public hearing.⁹² 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.⁹³ MDUFA performance goals have been established to reduce the review time for PMAs.⁹⁴

The Safe Medical Devices Act of 1990 (SMDA, P.L. 101-629) authorized the Humanitarian Device Exemption (HDE) to encourage the development of devices that aid in the treatment and diagnosis of diseases or conditions that affect fewer than 4,000 individuals in the United States per year. An HDE application is similar to a PMA, but is exempt from the effectiveness requirements to encourage manufacturers to develop devices for these small markets.

However, there are some important restrictions: there is a 4,000-unit limit per year on the number of devices shipped, and use of an HDE device requires approval by an institutional review board (IRB) at the institution where the device is to be used.⁹⁵ The IRB process can involve "substantial costs for meticulous record keeping, application production, and IRB fees (which could involve hundreds of sites)."⁹⁶ Also, there is "the potential for insurers not to cover the device (for lack of evidence of efficacy)."⁹⁷

In the past, the device sponsor was also not allowed to make a profit on the sale of the HDE device if its price was more than $250. FDAAA (P.L. 110-85) removed the restriction on profit for HDEs developed for pediatric use and required GAO to report by 2012 on the impact of removing this restriction.⁹⁸ FDASIA allows an HDE device to qualify for an exemption to the general ban on selling such devices for a profit if the HDE device is intended for the treatment or diagnosis of (1) a disease or condition that does not occur in pediatric patients, or (2) that occurs in pediatric patients in such numbers that device development is impossible, highly impracticable, or unsafe.⁹⁹ Also, a sponsor of a device granted an HDE prior to FDASIA's enactment may seek a determination as to whether it would qualify for an exemption to the profit ban.

In order for a device to receive HDE marketing approval, there cannot be another legally marketed device, either via the 510(k) process or the PMA process, available to treat or diagnose the disease or condition. Once a device with the same intended use as the humanitarian use device is approved or cleared, an HDE cannot be granted for the humanitarian use device.¹⁰⁰ However, the agency will "consider an HDE application if a comparable device has been approved under another HDE or if a comparable device is being studied under an IDE."¹⁰¹

Once approved or cleared for marketing, manufacturers of medical devices must comply with various regulations on postmarketing surveillance (including device tracking and adverse event reporting), labeling and advertising, and manufacturing. This section describes such requirements as well as efforts under development—the Sentinel Initiative and the Unique Device Identification (UDI) system—and CDRH compliance and enforcement actions.

Because the premarket review process cannot be designed to completely ensure the safety of all devices before they enter the market, it is essential to have a strong surveillance system that monitors the safety of medical devices. When a problem is identified with a particular medical device, various corrective actions are then implemented. The 2011 IOM report recommended that FDA "develop and implement a comprehensive strategy to collect, analyze, and act on medical-device postmarket performance information."¹⁰²

In response to the IOM recommendation, in September 2012 CDRH released a report proposing four specific actions to strengthen the U.S. medical device postmarket surveillance system.¹⁰³ The four actions are (1) establish a UDI system and promote its incorporation into electronic health information; (2) promote the development of national and international device registries for selected products; (3) modernize adverse event reporting and analysis; and (4) develop and use new methods for evidence generation, synthesis, and appraisal. The agency held a series of meetings in September 2012 in order to solicit public comments regarding the U.S. medical device postmarket surveillance system.¹⁰⁴

Corrective actions to a problem identified through postmarketing surveillance 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.¹⁰⁵

For certain class II and class III devices, FDA may order a manufacturer to conduct a postmarket surveillance study—also called a 522 study—once the device is approved or cleared for marketing in order to gather safety and efficacy data. A postmarket surveillance study may be ordered if

• device failure would be reasonably likely to have serious adverse health consequences;
• the device is expected to have significant use in pediatric populations;
• the device is intended to be implanted in the body for more than one year; or
• the device is intended to be a life-sustaining or life-supporting device used outside a device user facility.¹⁰⁶

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.¹⁰⁷

FDASIA specifies that the Secretary's authority to order the conduct of postmarket surveillance is at the time of approval or clearance of a device or at any time thereafter.¹⁰⁸ It also requires the manufacturer to commence any required postmarket surveillance not later than 15 months after being so ordered.

FDAAA required the HHS Secretary to promulgate regulations establishing a unique device identification (UDI) system.¹²⁷ FDASIA requires the Secretary to issue proposed regulations for UDI system not later than December 31, 2012.¹²⁸ These were published July 10, 2012.¹²⁹ It also required that proposed regulations be finalized no later than six months after the close of the comment period and final regulations be implemented with respect to certain devices no later than two years after finalization of the regulations.

When implemented, the new UDI system will require

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."¹³⁶ "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.¹³⁷

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."¹³⁸

All devices must conform to the general labeling requirements. ¹³⁹ 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.¹⁴⁰

A section of the Quality Systems Regulation (QSR) also has an impact on various aspects of labeling.¹⁴¹ 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.

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.¹⁴² 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 is analyzed to identify and correct quality problems; and that complaints are processed. FDA monitors device problem data and inspects the operations and records of device developers and manufacturers to determine compliance with the GMP requirements.¹⁴³ 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.

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.

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 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),¹⁴⁴ 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.

A recall is a method of removing or correcting products that FDA considers are in violation of the law.¹⁴⁶ Medical device recalls are usually conducted voluntarily by the manufacturer after negotiation with FDA.¹⁴⁷ 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.¹⁴⁸ 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.¹⁴⁹

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.

FDASIA requires the Secretary to establish a program to improve the device recall system.¹⁵¹ Among other things, it requires an assessment of information on device recalls, an assessment of the effectiveness of corrections or action plans for recalls, and documentation of the basis for terminations of recalls.

The Federal Food, Drug and Cosmetics Act of 1938

U.S. Supreme Court 1996 Opinion Medtronic v. Lohr

Medical Device User Fee Acts

FDA Amendments Act of 2007

FDA Safety and Innovation Act

The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA, P.L. 112-144) amended the FFDCA and the PHSA to reauthorize the prescription drug and medical device user fee programs, created new user fee programs for generic and biosimilar drug approvals, and modified FDA authority to regulate medical products. Several provisions in FDASIA made modifications to various aspects of premarket and postmarket device regulation. Examples of premarket changes include those which affect the efficiency, transparency, and data requirements of the 510(k) and PMA processes; and alter or make clarifications to certain types of exempt devices, for example, custom devices and humanitarian use devices. Provisions affecting postmarket regulation include those which focus on expanding active postmarket surveillance; altering requirements related to postmarket studies for devices; and strengthening both device recall and tracking capabilities through a recall program and the unique device identifier system. Miscellaneous reforms include those aimed at increasing transparency of FDA's approval and clearance decisions and processes for issuing industry guidance documents; improving health information technology for the agency; and harmonizing device regulation with FDA's international counterparts.

Footnotes

The Lewin Group, for AdvaMed, State Economic Impact of the Medical Technology Industry, June 7, 2010, p. 19.

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.

For more information on medical device user fees, see CRS Report R42508, The FDA Medical Device User Fee Program, by [author name scrubbed].

FDA also funds some device and radiological health activities with fees collected under the Mammography Quality Standards Act (MQSA, P.L. 102-539), and device user fees fund some non–device-specific activities at FDA.

Title VI of FDASIA addresses the regulation of medical devices; for further information see CRS Report R42680, The Food and Drug Administration Safety and Innovation Act (FDASIA, P.L. 112-144), coordinated by [author name scrubbed].

PriceWaterhouseCoopers / National Venture Capital Association, "Medical Devices and Equipment," Money Tree Report, data provided by Thomson Reuters, at http://www.pwcmoneytree.com.

Ernst and Young. Pulse of the industry: Medical technology report, 2012, p. 21. http://www.ey.com/Publication/vwLUAssets/Pulse_medical_technology_report_2012/$FILE/Pulse_medical_technology_report_2012.pdf

Ibid., p. 40.

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.

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.

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.

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; GAO, High-Risk Series: An Update, GAO-11-278, February 2011; and, GAO, High-Risk Series: An Update, GAO-13-283, February 2013.

(21 CFR 862-892).

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.

In vitro diagnostic products (IVDs, or laboratory tests) have their own unique premarket requirements and are not discussed further in this report.

This is somewhat similar to the process FDA uses to approve a new prescription drug. For information on the drug approval process, see CRS Report R41983, How FDA Approves Drugs and Regulates Their Safety and Effectiveness, by [author name scrubbed].

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).

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.

FFDCA §513(a)(1); see also 21 CFR §860.3(c). The agency has developed classifications for over 1,700 distinct types of devices and grouped them into 16 classification panels, such as "cardiovascular devices" or "ear, nose, and throat devices." FDA, Medical Devices, Classify Your Medical Device, December 3, 2012, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm.

See FDA, General and Special Controls, April 30, 2009, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/GeneralandSpecialControls/default.htm.

21 CFR 807.20

21 CFR 820

21 CFR 801 or 809.10.

FFDCA §513(a)(1)(A).

See 21 CFR 862 to 892.

FFDCA §513(a)(1)(B).

IOM, Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years, Washington, DC, July 2011, p. 40.

FDA, Overview of Medical Device Regulation, Medical Device Classification, Class I/II Exemptions, at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051549.htm.

FFDCA §513(a)(1)(C).

FFDCA §513(f)(2).

IOM, Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years, Washington, DC, July 2011, p. 81.

FDA, Overview of Medical Device Regulation, General and Special Controls, at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/GeneralandSpecialControls/default.htm.

FDA, CDRH Transparency, 515 Program Initiative, at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm240310.htm.

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.

Ibid., p. E2.

FDA, CDRH Transparency, 515 Program Initiative, at http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHTransparency/ucm240310.htm.

FDA, CDRH Transparency, 515 Program Status, at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm240318.htm.

Section 608(b) of FDASIA amended FFDCA section 515(b).

Examples include external cardiac compressor, including cardiopulmonary resuscitation (CPR) aids, from class III device into class II, 78 Federal Register 1162-1166, January 8, 2013; blade-form endosseous dental implant, from class III device into class II, 78 Federal Register 2647-2650, January 14, 2013; and, temporary mandibular condyle prosthesis, a class III device, into class II (and rename the device "temporary mandibular condyle reconstruction plate"), 78 Federal Register 9010-9015, February 7, 2013.

Food and Drug Administration, "Effective Date of Requirement for Premarket Approval for Two Class III Preamendment Devices," 78 Federal Register 4094-4100, January 18, 2013.

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, 112^th Cong., 1^st sess., April 13, 2011.

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.

U.S. Congress, Senate Committee on Health, Education, Labor, and Pensions, Medical Devices: Protecting Patients and Promoting Innovation, 112^th Cong., 1^st sess., November 15, 2011.

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.

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.

FDA, Medical Devices, Important Information on the Medical Device User Fee Rates for FY2012, at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm266885.htm

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.

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, 112^th Cong., 1^st sess., November 15, 2011, http://help.senate.gov/imo/media/doc/Shuren.pdf.

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.

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.

Ibid., p. 27.

FDA, Medical Devices, 510(k) Submission Methods, at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134034.htm

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.

FDA, How to Prepare a Traditional 510(k), September 14, 2009; http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134572.htm#link_4.

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.

21 CFR 807.100(a).

21 CFR 807.87(l).

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.

21 CFR 10.115. FDA continually accepts public comment on any draft or final guidance document.

21 CFR 861.

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.

21 CFR 820.30.

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.

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.

FDASIA §607.

For example, 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. In addition, 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. FDA review of medical products has been included in these reports. See GAO, High-Risk Series: An Update, GAO-09-271, January 2009; GAO, High-Risk Series: An Update, GAO-11-278, February 2011; and, GAO, High-Risk Series: An Update, GAO-13-283, February 2013.

P.L. 110-85, sec. 225.

See last four paragraphs of "Device Classification" section in this report. FDASIA changed the process for the reclassification of a device from rulemaking to an administrative order.

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, http://www.gao.gov/new.items/d09190.pdf.

In January 2009 CDRH scientists sent letters to Congressional Committees and to the Obama transition team regarding the ReGen Menaflex device. See Alicia Mundy, "Political Lobbying Drove FDA Process," The Wall Street Journal, March 6, 2009. A May 11, 2009, letter to Acting Commissioner Sharfstein from Members of the House Committee on Energy and Commerce indicated that the process used by FDA to clear the ReGen Menaflex device was under investigation by the Committee and the letter outlined concerns with the process. See http://democrats.energycommerce.house.gov/Press_111/20090511/fdaregen.pdf. The ReGen Menaflex device was under investigation on the Senate side as well; Senator Charles Grassley "wrote to FDA and ReGen in March 2006 regarding allegations that ReGen influenced FDA's actions on the device." http://www.grassley.senate.gov/news/Article.cfm?customel_dataPageID_1502=23269

FDA, Review of the ReGen Menaflex: Departures from Processes, Procedures and Practices Leave the Basics for a Review Decision in Question, September 2009, p. 8, http://www.fda.gov/downloads/NewsEvents/PublicHealthFocus/UCM183642.pdf. See also: http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm183745.htm; and, Transcript for FDA's Media Briefing on the FDA's Review of the ReGen Menaflex, September 24, 2009, http://www.fda.gov/downloads/NewsEvents/Newsroom/MediaTranscripts/UCM184027.pdf.

See Attachment 3B at http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm183745.htm.

FDA, Review of the ReGen Menaflex: Departures from Processes, Procedures and Practices Leave the Basics for a Review Decision in Question, September 2009, p. 2, http://www.fda.gov/downloads/NewsEvents/PublicHealthFocus/UCM183642.pdf.

Transcript for FDA's Media Briefing on the FDA's Review of the ReGen Menaflex, September 24, 2009, p. 2, http://www.fda.gov/downloads/NewsEvents/Newsroom/MediaTranscripts/UCM184027.pdf. On October 14, 2010, FDA announced that Menaflex "should not have been cleared for marketing in the United States. … To correct this error, the agency will begin the process to rescind the product's marketing clearance." http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm229384.htm.

FDA, "Institute of Medicine to Study Premarket Clearance Process for Medical Devices," press release, September 23, 2009, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2009/ucm183497.htm.

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, 112^th Cong., 1^st sess., April 13, 2011.

FDA, "FDA Issues Assessments of the 501(k) Program and Use of Science in Decision-Making," press release, August 4, 2010, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm221166.htm.

FDA, "FDA to improve most common review path for medical devices," press release, January 19, 2011, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm240418.htm.

See, FDA, About FDA, CDRH Plan of Action for 510(k) and Science, at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/ucm239448.htm

IOM, Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years, Washington, DC, July 2011.

Ibid., Recommendation 7-1.

FDA, Medical Devices, Premarket Approval (PMA), at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/default.htm.

FFDCA §513(a)(1)(C); 21 CFR 814.

A December 2009 report in JAMA found that 65% of all PMA applications for cardiovascular devices are based on a single study that often is not a high quality randomized controlled or blinded clinical trial (in which the study participants, caregivers, or outcome assessors are prevented from knowing which intervention was received.) The report found that 27% of all cardiovascular PMAs were based on a randomized trial, and 14% of such trials were blinded. In addition, a majority of the cardiovascular studies used surrogate end points "which may not be reliable predictors of actual patient benefit." A surrogate end point of a clinical trial "is a laboratory measurement or a physical sign used as a substitute for a clinically meaningful end point that measures directly how a patient feels, functions, or survives." Cardiovascular devices were examined "because it was expected they would undergo the most stringent approval process given their far-reaching impact on morbidity and mortality and their increasing use." The authors state that their findings "raise serious questions about the quality of data on which some cardiovascular device approvals are based." They argue that in comparison with drug approval, "the bar for evidence of benefit should be higher for devices because they are implanted and cannot simply be discontinued, as drugs can. ... The importance of FDA device approval is magnified as it preempts consumer lawsuits on device safety" leaving injured patients no avenue of legal recourse or redress. Sanket S. Dhruva, Lisa A. Bero, and Rita F. Redberg, "The strength of study evidence examined by the FDA in premarket approval of cardiovascular devices," Journal of the American Medical Association, vol. 302, no. 24 (December 23, 2009), pp. 2679-2685.

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).

FDA, Device Advice: Investigational Device Exemption (IDE), July 9, 2009, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/default.htm.

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.

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 [author name scrubbed] (pdf).

21 CFR 820.

For further information, see CRS Report RS22691, FDA Advisory Committee Conflict of Interest, by [author name scrubbed].

21 CFR 14.

For example, see figure in testimony of CDRH Director Jeffrey Shuren before the Senate HELP Committee, March 29, 2012, at http://www.fda.gov/NewsEvents/Testimony/ucm297418.htm See also 21 CFR 814.40.

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 MDUFA, see CRS Report R42508, The FDA Medical Device User Fee Program, by [author name scrubbed]. For further information on PDUFA, see CRS Report RL33914, The Prescription Drug User Fee Act: History Through the 2007 PDUFA IV Reauthorization, by [author name scrubbed].

21 CFR 814.100, 814.104(b)(5), and 814.124.

IOM, Rare Diseases and Orphan Products: Accelerating Research and Development, Washington, DC, 2010, p. 236, http://books.nap.edu/catalog.php?record_id=12953.

Ibid.

U.S. Government Accountability Office, Pediatric Medical Devices: Provisions Support Development, but Better Data Needed for Required Reporting, 12-225, December 20, 2011, http://gao.gov/assets/590/587164.pdf.

Section 613 of FDASIA.

For additional information, see Guidance for Industry and FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers, July 18, 2006, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071473.htm.

IOM, Rare Diseases and Orphan Products: Accelerating Research and Development, Washington, DC, 2010, p. 216, http://books.nap.edu/catalog.php?record_id=12953.

IOM, Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years, Washington, DC, July 2011, Recommendation 7-2.

FDA Center for Devices and Radiological Health, Strengthening Our National System for Medical Device Postmarket Surveillance, Silver Spring, MD, September 2012, http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/UCM301924.pdf.

Public Meeting - Strengthening the National Medical Device Postmarket Surveillance System, September 10, 2012, http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm300721.htm; Public Workshop - MDEpiNet 2012 Annual Meeting: The Medical Device Epidemiology Network as a Partnership for Building Global Medical Device Epidemiology and Surveillance Capabilities, September 11, 2012, http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm300722.htm; Public Workshop - Leveraging Registries With Medical Device Data for Postmarket Surveillance and Evidence Appraisal Throughout the Total Product Life Cycle, September 12-13, 2012, http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm300724.htm.

FFDCA §522.

FFDCA §522; a device user facility means a hospital, ambulatory surgical facility, nursing home, or outpatient treatment facility which is not a physician's office.

Further information, and a listing of 522 studies, can be found at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/PostmarketSurveillance/ucm134497.htm

Section 616 of FDASIA.

FFDCA §519(a)

The searchable MDR database for devices is publically accessible at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmdr/search.CFM.

21 CFR 803.10(c)(1) and 803.10(c)(2)

21 CFR 803.10(a)(1)(i).

21 CFR 803.10(a)(1)(ii).

21 CFR 803.10(a)(2) and 803.33.

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.

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.

FDA, Medical Device Tracking, May 13, 2009, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/MedicalDeviceTracking/default.htm#link_2.

21 CFR 821

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.

FFDCA §505(k); 21 USC 355

FFDCA §1003(b)(2)(c)

Section 615 of FDASIA.

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.

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.

IOM, Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years, Washington, DC, July 2011, p. 106.

Information on the current status of the Sentinel Initiative is available at http://www.fda.gov/Safety/FDAsSentinelInitiative/default.htm.

FFDCA §519(f); 21 USC 360i

Section 614 of FDASIA.

Food and Drug Administration, "Unique Device Identification System," 77 Federal Register 40735-40778, July 10, 2012. An amendment to the proposed rule was published in the Federal Register on November 19, 2012, 69393-69399.

FDA, "Unique Device Identification for Postmarket Surveillance and Enforcement; Public Workshop," 76 Federal Register 43691-43693, July 21, 2011.

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.

Alaina Bush, "CER, Safety uses eyed as part of FDA device identification rule," Inside Health Reform, vol. 3, no. 39 (September 22, 2011).

Meeting information, reports and current status of the UDI system can be found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm

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.

FFDCA §201(k)

FFDCA §201(m)

United States v. Research Laboratories, Inc., 126 F.2d 42 (9^th Cir. 1942).

21 CFR 801

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.

21 CFR 820.120

FFDCA §520; 21 CFR 820

FDA, Medical Devices: 1. The Quality System Regulation, June 18, 2009, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/MedicalDeviceQualitySystemsManual/ucm122391.htm.

See ORA at http://www.fda.gov/AboutFDA/CentersOffices/ORA/default.htm.

Warning letters are publically available on FDA's website at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm.

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).

21 CFR 7

21 CFR 806.

21 CFR 810. See out-of-print CRS Report RL34167, The FDA's Authority to Recall Products, by [author name scrubbed] (available from the author upon request).

The main page for recalls, market withdrawals, and safety alerts for all FDA-regulated products is http://www.fda.gov/opacom/7alerts.html.

Section 605 of FDASIA.

U.S. Congress, House Committee on Interstate and Foreign Commerce, Medical Device Amendments of 1976, to accompany H.R. 11124, 94^th Cong., 2^nd sess., February 29, 1976, H. Rept. 94-853, p. 6.

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."

Ibid.

Ibid., p. 7.

Ibid., p. 7-8.

Ibid., p. 8. By 1975, the Dalkon Shield had been linked to at least 16 deaths and 25 miscarriages, numerous cases of 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.

U.S. Congress, House Committee on Interstate and Foreign Commerce, Medical Device Amendments of 1976, to accompany H.R. 11124, 94^th Cong., 2^nd sess., February 29, 1976, H. Rept. 94-853, p. 8-9.

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).

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.

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 the first cadre of "predicate" devices in order to demonstrate substantial equivalence.

Ibid., p. 24.

Ibid., p. 177.

Ibid., p. 25.

Ibid., p. 179.

Ibid. p. 180.

FFDCA §515(i).

IOM, Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years, Washington, DC, July 2011, p. 205.

FFDCA §513(i).

IOM, Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years, Washington, DC, July 2011, p. 28.

Ibid., p. 213.

FFDCA §513(i)(1)(D).

FFDCA §515(d)(5).

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.

See CRS Report RL34465, FDA Amendments Act of 2007 (P.L. 110-85), by [author name scrubbed].

See the Clinical Trials Databases section of CRS Report RL34465, FDA Amendments Act of 2007 (P.L. 110-85), by [author name scrubbed].

FDA uses advisory committees to gain independent advice from outside experts. See CRS Report RS22691, FDA Advisory Committee Conflict of Interest, by [author name scrubbed].