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The FDA Medical Device User Fee Program
Judith A. Johnson
Specialist in Biomedical Policy
April 24, 2012
Congressional Research Service
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CRS Report for Congress
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The FDA Medical Device User Fee Program

Summary
The Food and Drug Administration (FDA) is the agency responsible for the regulation of medical
devices. These are a wide range of products that are used to diagnose, treat, monitor, or prevent a
disease or condition in a patient. A company must obtain FDA’s prior approval or clearance
before marketing many medical devices in the United States. The Center for Devices and
Radiological Health (CDRH) within FDA is primarily responsible for medical device review and
regulation.
Congress first gave FDA the authority to collect user fees from medical device companies in the
Medical Device User Fee and Modernization Act of 2002 (P.L. 107-250). The purpose of the user
fee program is to help reduce the time in which FDA can review and make decisions on
marketing applications. Lengthy review times affect the industry, which waits to market its
products, and patients, who wait to use these products. The user fee law provides a revenue
stream for FDA; in conjunction, the agency negotiates with industry to set performance goals for
the premarket review of medical devices. Reauthorization of FDA’s medical device user fees last
occurred in 2007, just before the FDA’s authority would expire, via the Medical Device User Fee
Amendments of 2007 (MDUFA II). Current authority will expire on October 1, 2012.
On February 1, 2012, FDA announced that it had reached “an agreement in principle” with the
medical device industry on proposed recommendations for the second reauthorization—referred
to as MDUFA III. A draft MDUFA III package, composed of statutory language and the FDA-
industry agreement on performance goals and procedures, was posted on the FDA website on
March 14, 2012, and a public meeting describing the draft was held on March 28, 2012. The 30-
day comment period on the draft ended April 16, 2012. Following review of the comments, FDA
may revise the recommendation and then is to submit the final package to Congress.
Since medical device user fees were first collected in FY2003, they have comprised an increasing
proportion of FDA’s device budget. Medical device user fees have raised a number of concerns,
prompting Congress to carefully consider issues such as which agency activities could use fees,
how user fees can be kept from supplanting federal funding, and which companies should qualify
as a small business and pay a reduced fee.
Congress is also considering reauthorization of the Prescription Drug User Fee Act (PDUFA) as
well as new proposals for a Generic Drug User Fee Act and a Biosimilars User Fee Act. It is
likely that these three will be combined with MDUFA III along with a variety of related and
unrelated issues. Because of the importance of user fees to FDA’s budget, PDUFA and MDUFA
are considered to be “must pass” legislation, and Congress has often in the past included language
to address a range of other concerns. For example, MDUFA II included provisions about the
extent to which FDA can delegate activities to third parties, a unique device identification system,
and reporting requirements for devices linked to serious injuries or deaths. House and Senate
committees are circulating discussion drafts that contain many proposals that would affect
medical device regulation. FDA has indicated that some of these pending reforms could conflict
with what was negotiated with industry in the MDUFA III proposal. Some reforms are of concern
because they would require more agency resources; others were discussed during the user fee
negotiations and were set aside. If MDUFA reauthorization does not occur by early summer,
federal regulations require that reduction-in-force notices be sent out in July 2012, giving 60
days’ advance notice to about 250 FDA employees that their employment under the MDUFA
program would end September 30, 2012.
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Contents
Introduction...................................................................................................................................... 1
Current Law..................................................................................................................................... 2
FDA Premarket Review of Medical Devices ............................................................................ 3
Medical Device User Fees......................................................................................................... 4
Exemptions and Discounted Fees.............................................................................................. 5
Use of User Fees........................................................................................................................ 6
Other MDUFA Requirements.................................................................................................... 7
MDUFA Impact on FDA Review Time and Budget........................................................................ 8
MDUFA III Proposal ..................................................................................................................... 13
Draft Legislative Language ..................................................................................................... 14
Draft Industry-FDA Performance Goals and Procedures for MDUFA III: The
Agreement ............................................................................................................................ 15
Other Potential Issues .............................................................................................................. 17

Figures
Figure 1. Medical Devices Listed with FDA, FY2003-FY2007, by Premarket
Review Process............................................................................................................................. 3
Figure 2. Average Time to Decision: 510(k)s .................................................................................. 9
Figure 3. Average Time to Decision: PMAs and Panel Track Supplements.................................. 10
Figure 4. Devices and Radiological Health Program Budget, by Funding Source, for
FY2002 to FY2013..................................................................................................................... 12

Tables
Table 1. FDA Devices and Radiological Health Program, Fees as a Percentage of Total
Program Level ............................................................................................................................ 12
Table A-1. Provisions in Section 737 and 738 of the Federal Food, Drug, and Cosmetic
Act Relating to Medical Device User Fees................................................................................. 19
Table A-2. Provisions in Draft MDUFA III Legislative Language That Would Add Two
New Sections to Chapter VII of the Federal Food, Drug, and Cosmetic Act ............................. 23
Table B-1. Performance Goals and Procedures in Agreement Between FDA and Industry
Representatives for FY2013 through FY2017 Under the Draft MDUFA III.............................. 24
Table C-1. MDUFMA/MDUFA 2007 Fee Schedule, FY2007-FY2012........................................ 29
Table D-1. Summary of Performance Goals per February 7, 2012, Agreement............................ 30

Appendixes
Appendix A. Provisions in FFDCA §737 and §738....................................................................... 19
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Appendix B. MDUFA III Agreement: Performance Goals and Procedures .................................. 24
Appendix C. MDUFMA and MDUFA: Fees and Performance Goals........................................... 29
Appendix D. MDUFA III Performance Goals ............................................................................... 30
Appendix E. Acronyms Used in This Report................................................................................. 32

Contacts
Author Contact Information........................................................................................................... 32

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Introduction
In 2002, the Medical Device User Fee and Modernization Act (MDUFMA) gave the Food and
Drug Administration (FDA) the authority to collect fees from the medical device industry.1 User
fees and direct appropriations from Congress fund review of medical devices by the FDA.
Medical devices are a wide range of products that are used to diagnose, treat, monitor, or prevent
a disease or condition in a patient. The Federal Food, Drug and Cosmetic Act (FFDCA) defines a
medical device as
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 its primary 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. (FFDCA §201(h), 21 U.S.C. 301 §201(h))
According to FDA, examples of medical devices “range from simple tongue depressors and
bedpans to complex programmable pacemakers with micro-chip technology and laser surgical
devices.”2 Medical devices also include in vitro diagnostic products, reagents, test kits, and
certain electronic radiation-emitting products with medical applications, such as diagnostic
ultrasound products, x-ray machines, and medical lasers.
Manufacturers must obtain FDA approval or clearance before marketing many medical devices in
the United States. The Center for Devices and Radiological Health (CDRH) has primary
responsibility within FDA for medical device premarket review.3 The purpose of user fees is to
support the FDA’s medical device premarket review program and to help reduce the time it takes
the agency to review and make decisions on marketing applications. Prior to 2002, multiple
government reports, as early as 1983, indicated that FDA had insufficient resources for its
medical devices premarket review program.4 Lengthy review times affect the industry, which
waits to market its products, and patients, who wait to use these products. The user fee law
provides revenue for FDA; in conjunction, the agency negotiates with industry to set performance
goals
for the premarket review of medical devices. The medical device user fee program was
modeled after the Prescription Drug User Fee Act (PDUFA).5

1 MDUFMA (P.L. 107-250) added Sections 737 and 738 to the Federal Food, Drug and Cosmetic Act (FFDCA) [21
USC 379i and 379j]. MDUFMA was amended twice by the Medical Device Technical Corrections Act of 2004
(MDTCA; P.L. 108-214) and the Medical Device User Fee Stabilization Act of 2005 (MDUFSA; P.L. 109-43).
2 FDA, Medical Devices, “Is the Product a Medical Device,” at http://www.fda.gov/medicaldevices/
deviceregulationandguidance/overview/classifyyourdevice/ucm051512.htm.
3 Another center, the Center for Biologics Evaluation and Research (CBER), regulates devices associated with blood
collection and processing procedures, cellular products, and tissues. For more information, see CRS Report R42130,
FDA Regulation of Medical Devices, by Judith A. Johnson.
4 These reports are listed in Institute of Medicine (IOM), Medical Devices and the Public’s Health: The FDA 510(k)
Clearance Process at 35 Years
, Washington, DC, July 2011, p. 30, http://www.iom.edu/Reports/2011/Medical-
Devices-and-the-Publics-Health-The-FDA-510k-Clearance-Process-at-35-Years.aspx.
5 PDUFA came about following negotiations among the FDA (under Commissioner David Kessler), the drug industry,
and key congressional committee Members and staff. The aim of the negotiations was “getting enough qualified
(continued...)
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Like the prescription drug and animal drug user fee programs, the medical device user fee
program has been authorized in five-year increments.6 FDA’s medical device user fee authorities
were reauthorized just before their expiration by the Medical Device User Fee Amendments of
2007 (MDUFA).7 The agency’s current authority to collect medical device user fees will expire
on October 1, 2012.
On February 1, 2012, FDA announced that it had reached “an agreement in principle” with the
medical device industry on proposed recommendations for the reauthorization of the medical
device user fee program.8 Referred to as MDUFA III, a draft of the negotiated package—
composed of statutory language and the FDA-industry agreement on performance goals and
procedures—was posted on the FDA website on March 14, 2012.9 A public meeting describing
the draft was held on March 28, 2012. The 30-day comment period on the draft ended April 16,
2012. Following review of the comments, FDA may revise the recommendation and then is to
submit the final package to Congress.
This report describes current law regarding medical device user fees, the impact of MDUFA on
FDA review time of various medical device applications and the agency’s medical device
program budget, the MDUFA III proposal (legislative language and performance goals
agreement), and issues that Congress is likely to take up as it works on the reauthorization of the
medical device user fee program. Appendix E provides a list of acronyms used in this report.
Current Law
The Medical Device Amendments of 1976 (P.L. 94-295) was the first major legislation passed to
address the premarket review of medical devices. User fees to support the FDA’s medical device
premarket review program were first authorized by Congress in 2002, 10 years after Congress

(...continued)
doctors onto the FDA staff to carry out drug reviews, and getting the company staffs to cooperate in meeting higher
standards. The solution that emerged was one intended to bypass the anachronistic and unreliable congressional system
that always underfinanced the FDA.” Phillip J. Hilts, Protecting America’s Health (New York: Alfred A. Knopf, 2003),
p. 278. Other key features of PDUFA include ensuring that the user fee revenue would not go to general funds but
could be spent only on the drug review program, a sunset provision ensuring the user fee program would be reevaluated
every five years, and “an implicit contract by Congress not to exploit the availability of the user fee monies and then
reduce FDA appropriations for drug review-related purposes.” Daniel Carpenter, Reputation and Power:
Organizational Image and Pharmaceutical Regulation at the FDA
(Princeton, NJ: Princeton University Press, 2010),
pp. 459-460.
6 See CRS Report R42366, Prescription Drug User Fee Act (PDUFA): Issues for Reauthorization (PDUFA V) in 2012,
by Susan Thaul, and CRS Report RL34459, Animal Drug User Fee Programs, by Sarah A. Lister.
7 MDUFA was enacted as Title II of the Food and Drug Administration Amendments Act of 2007 (FDAAA; P.L. 110-
85). See CRS Report RL34465, FDA Amendments Act of 2007 (P.L. 110-85), by Erin D. Williams and Susan Thaul.
8 Food and Drug Administration, “FDA and Industry reach agreement in principle on medical device user fees,” press
release, February 1, 2012, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm289828.htm. FDA
and industry missed the January 15, 2012, statutory deadline for transmitting the MDUFA III package to Congress,
delaying the reauthorization process and possibly jeopardizing completion before the medical device user fee program
sunsets on September 30, 2012.
9 FDA, “Draft MDUFA III Commitment Letter,” dated February 17, 2012, and posted on FDA website March 14,
2012, at http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM295454.pdf.
Document is referred to, at times, as the Commitment Letter or the Agreement. FDA, draft statutory language dated
February 17, 2012, and posted at http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/
UCM295424.pdf.
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had provided the authority for prescription drug user fees via PDUFA. For prescription drugs, the
manufacturer must pay a fee for each new drug application (NDA) that is submitted to FDA for
premarket review. In contrast, most medical devices are exempt from premarket review and do
not pay a user fee. Premarket review and payment of the associated fee is required for about a
third of the medical devices listed with FDA (see Figure 1).
Figure 1. Medical Devices Listed with FDA, FY2003-FY2007, by Premarket
Review Process

Source: Government Accountability Office, January 2009, GAO-09-190, p. 9.
Notes: “Other” includes devices that were allowed to enter the market via other means, such as through the
humanitarian device exemption process that allows market entry, without adherence to certain requirements,
for devices benefiting patients with rare diseases or conditions. See “Exemptions and Discounted Fees.” Non-
exempt devices are reviewed by FDA via the PMA (premarket approval) process or the 510(k) notification. See
“FDA Premarket Review of Medical Devices.”
FDA Premarket Review of Medical Devices
FDA classifies devices based on the risk to the patient: low-risk devices are Class I, medium-risk
are Class II, and high-risk are Class III. Low-risk medical devices (Class I) and a very small
number of moderate-risk (Class II) medical devices are exempt from premarket review. In
general, for moderate-risk and high-risk medical devices, there are two pathways that
manufacturers can use to bring such devices to market with FDA’s permission. 10
One pathway consists of conducting clinical studies, then submitting a premarket approval
(PMA) application with evidence providing reasonable assurance that the device is safe and
effective. 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.

10 Novel devices lacking a legally marketed predicate are automatically designated Class III. FFDCA Section 513(f)
established an expedited mechanism for reclassifying these devices based on risk, 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 PMA application. For more information on device classification and the FDA review process, see
CRS Report R42130, FDA Regulation of Medical Devices, by Judith A. Johnson.
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Another pathway involves submitting a premarket notification submission—also known as a
510(k), after the section in the FFDCA that authorized this type of notification. With the 510(k),
the manufacturer demonstrates 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 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.
Medical Device User Fees
Premarket review by FDA—both PMA and 510(k)—requires the payment of a user fee. FDA
typically evaluates more than 4,000 510(k) notifications and about 40 original PMA applications
each year.11 Since MDUFA II reauthorization in 2007, FDA cleared over 13,000 510(k) devices
and approved 106 PMAs.12 According to CDRH Director Jeffrey Shuren, for FY2010, user fees
collected under MDUFA “fund only about 20% of the device review program”; in contrast, user
fees collected under the PDUFA account for over 60% of the drug review program’s budget.13
There are also fees for when a manufacturer requests approval of a significant change in the
design or performance of a device approved via the PMA pathway.14 This is called a Panel-Track
Supplement when it is necessary for FDA to evaluate significant clinical data in order to make a
decision on approval of the supplement. If a manufacturer requests approval of a change in
aspects of an approved device, such as its design, specifications, or labeling, this is called a 180-
Day PMA Supplement. In this case, FDA either does not require new clinical data or requires
only limited clinical data. When a manufacturer requests approval for a minor change to an
approved device, such as a minor change in the design or labeling, this is called a Real-Time
PMA Supplement. With a Premarket Report, a manufacturer requests the approval of a high-risk
device, originally approved for single use (one patient, one procedure), for reprocessing to allow
additional use.
The original 2002 user fee law had only authorized FDA to collect fees for premarket review,
such as for PMA applications or 510(k) notifications. The 2007 reauthorization—MDUFA II—
added two new types of annual fees in order to generate a more stable revenue stream for the
agency. According to FDA, there were fluctuations in the numbers submitted from year to year,
and fee revenues repeatedly fell short of expectations.15 MDUFA II added establishment fees, paid
annually by most device establishments registered with FDA, and product fees, paid annually for
high-risk (Class III) devices for which periodic reporting is required. The annual fees were
projected to generate about 50% of the total device fee revenue from FY2008 to FY2012.16

11 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.
12 U.S. Congress, House Committee on Energy and Commerce, Subcommittee on Health, Reauthorization of MDUFA:
What it means for jobs, innovation and patients
, Statement of Jeffrey Shuren, CDRH Director, FDA, 112th Cong., 2nd
sess., February 15, 2012; and U.S. Congress, Senate Committee on Health, Education, Labor and Pensions, FDA User
Fee Agreements
, Statement of Jeffrey Shuren, CDRH Director, FDA, 112th Cong., 2nd sess., March 29, 2012.
13 Ibid.
14 FFDCA 738(a)(2)(A).
15 FDA, “Medical Device User Fee and Modernization Act; Public Meeting,” 72 Federal Register 19528, April 18,
2007.
16 FDA, “Medical Device User Fee and Modernization Act; Public Meeting,” 72 Federal Register 19528, April 18,
2007.
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MDUFA II also added two new application fees, the 30-Day Notice and 513(g) application, and
substantially lowered all the existing application fee amounts (see Table C-1). A manufacturer
uses a 30-Day Notice when requesting to make modifications to manufacturing procedures or
methods of manufacture affecting the safety and effectiveness of the device, and a manufacturer
requests information on the classification of a device with a 513(g) application.17
Other than the establishment fee, the amount of each type of user fee is set as a percentage of the
PMA fee, also called the base fee. The law prescribes both the base fee amount for each fiscal
year, and the percentage of the base fee that constitutes most other fees. For example, the 510(k)
fee is equal to 1.84% of the PMA fee. MDUFA II raised the PMA fee by 8.5% per year from
FY2008 to FY201218 (see Table C-1). FDA asserted that this annual increase would ensure that
fee revenues contribute their expected share to total program costs, and would provide industry
with stability and predictability in the fee revenues it would expect to pay.19 The amount of the
establishment fee (also known as the establishment registration fee) was authorized under
MDUFA II to rise 8.5% per year from FY2008 to FY201220 (see Table C-1).
Exemptions and Discounted Fees
Certain types of medical devices, sponsors of medical device PMA applications or 510(k)
notifications, and medical device manufacturers are exempt from paying fees, and small
businesses pay a reduced rate.21 Humanitarian Device Exemption (HDE) applications are exempt
from user fees, other than establishment fees.22 An HDE exempts devices that meet certain
criteria from the effectiveness requirements of premarket approval. Devices intended solely for
pediatric use are exempt from fees other than establishment fees.23 If an applicant obtains an
exemption under this provision, and later submits a supplement for adult use, that supplement is
subject to the fee then in effect for an original PMA.
State and federal government entities are exempt from fees for a PMA, premarket report,
supplement, 510(k), and establishment registration unless the device is to be distributed
commercially. Indian tribes are exempted from having to pay establishment registration fees,
unless the device is to be distributed commercially. Other than an establishment fee, the FDA
cannot charge a fee for premarket applications for biologics licenses and licenses for biosimilar or
interchangeable products if products are licensed exclusively for further manufacturing use.24

17 FFDCA 738(a)(2)(A)
18 FFDCA 738(b).
19 FDA, “Medical Device User Fee and Modernization Act; Public Meeting,” 72 Federal Register 19528, April 18,
2007. Under MDUFMA, base fees increased by 34% from FY2003 to FY2004, by 15.7% from FY2004 to FY2005,
and by 8.5% from FY2005 to FY2006 and FY2006 to FY2007.
20 The HHS Secretary had the authority to increase the establishment fee by up to an additional 8.5% (over the annual
8.5% increase) in FY2010 if fewer than 12,250 establishments paid the fee in FY2009. This measure was designed to
ensure that the establishment fees were 45% of total fees, ensuring that FDA had a stable funding base from user fees.
21 FFDCA 738(a)(2)(B); 21 USC 379j(a)(2)(b).
22 FFDCA 738(a)(2)(B)(i). HDE is intended 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. FFDCA
520(m); 21 USC 360j(m). The research and development costs of such devices could exceed the market returns for
products that address diseases or conditions affecting small patient populations.
23 FFDCA 738(a)(2)(B)(v)
24 FFDCA 738(a)(2)(B)(ii); FFDCA 738(a)(3)(A)
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Under a program authorized by Congress, FDA accredits third parties, allowing them to conduct
the initial review of 510(k)s for the purpose of classification of certain devices.25 The purpose is
to improve the efficiency and timeliness of FDA’s 510(k) process. No FDA fee is assessed for
510(k) submissions reviewed by accredited third parties, although the third parties charge
manufacturers a fee for their services.26
In MDUFA II, Congress amended the process of qualifying for small business user fee discounts
in response to frustrations expressed by domestic and foreign companies that had difficulties with
the requirements. Small businesses—those with gross receipts below a certain amount—pay
reduced user fees and have some fees waived altogether.27 These fee reductions and exemptions
are important, because many device companies are small businesses.28
Under current law, whether a device company is considered a small business eligible for fee
reductions or waivers depends on the particular fee. Small businesses reporting under $30 million
in gross receipts or sales are exempt from fees for their first PMA. Proof of receipts may consist
of IRS tax documents or qualifying documentation from a foreign government. Companies with
annual gross sales or receipts of $100 million or less pay at a rate of 50% of the 510(k) user fee,
30-day notice, request for classification information, and 25% of most other user fees.29 Small
businesses must pay the full amount of the establishment fees.
2007 GAO Study
A March 2007 Government Accountability Office (GAO) report analyzed company revenue information for 50% of
the “4,500 device applications subject to user fees that were submitted in FY2006.” The remaining 50% of applications
“were likely submitted by private companies that did not qualify as smal businesses,” and GAO was “unable to
identify the number of these companies.” For the companies that GAO was able to analyze, the report found that
95% of the 697 companies qualifying as small businesses in FY2006 had revenues below $30 million. Of these 697
companies, “two-thirds submitted at least one device application subject to user fees during that year. These
companies were responsible for about 20% of the approximately 4,500 device applications subject to user fees that
were submitted to FDA in FY2006.” GAO also analyzed the annual revenue for 258 publicly traded companies that
submitted applications subject to user fees and did not qualify as smal businesses in FY2006. Of these 258 companies,
155 (60%) had annual revenue higher than $500 million, 47 companies were above $100 million but at or below $500
million, and 56 companies were at or below the $100 million threshold for small business qualification. GAO did not
determine why these companies were not qualified as small businesses. These 258 publicly traded companies were
responsible for about 30% of the approximately 4,500 applications subject to user fees submitted to FDA in FY2006.
Source: GAO, “Food and Drug Administration: Revenue Information on Certain Companies Participating in the
Medical Device User Fee Program,” GAO-07-571R (March 30, 2007), at http://www.gao.gov/assets/100/94743.pdf.
Use of User Fees
A key element of FDA user fee laws—both MDUFA and PDUFA—is that the user fees are to
supplement congressional appropriations, not replace them. The law includes complex formulas,
called triggers, to enforce that goal. FDA may collect and use MDUFA fees only if the direct
appropriations for the activities involved in the premarket review of medical devices and for FDA

25 FFDCA 523.
26 FFDCA 738(a)(2)(B)(iv).
27 FFDCA 738(d),(e); 21 USC 379j(d),(e).
28 FDA, “Medical Device User Fee and Modernization Act; Public Meeting,” 72 Federal Register 19528, April 18,
2007.
29 FFCCA 738(d); 21 USC 379j(d).
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activities overall remain at a level at least equal (adjusted for inflation) to the pre-MDUFA
budget.30
Other MDUFA Requirements
Over time, Congress has changed PDUFA to allow user fee revenue to be used for not only FDA
activities related to premarket review but also the review of postmarket safety information
associated with a drug. In contrast, MDUFA revenue can be used only for activities associated
with FDA review of PMAs, 510(k)s, supplements, and reports. The law states that fees “shall
only be collected and available to defray increases in the costs of resources allocated for the
process for the review of device applications.” 31
MDUFA II added a new Section 738A regarding required reports and outlining the
reauthorization process. This section required the Secretary to submit annual fiscal and
performance reports for FY2008 through FY2012 to the Senate Committee on Health, Education,
Labor, and Pensions, and the House Committee on Energy and Commerce. Fiscal reports address
the implementation of FDA’s authority to collect medical device user fees, as well as FDA’s use
of the fees. Performance reports address FDA’s progress toward and future plans for achieving the
fee-related performance goals identified in the agreement.
The new section also directed the FDA to develop a reauthorization proposal for FY2013 through
FY2017 in consultation with specified congressional committees, scientific and academic experts,
health care professionals, patient and consumer advocacy groups, and the regulated industry.32
Prior to negotiations with industry, FDA was required to request public input, hold a public
meeting, and publish public comments on the agency’s website. During negotiations with
industry, FDA was mandated to hold monthly discussions with patient and consumer advocacy
groups to receive their suggestions and discuss their views on the reauthorization. After
negotiations with industry were completed, FDA was required to present the recommendations to
certain congressional committees, publish the recommendations in the Federal Register, provide
a 30-day public comment period, hold another public meeting to receive views from stakeholders,
and revise the recommendations as necessary. As explained earlier, the FDA missed the new
statutory deadline that required the transmittal of the revised recommendations to Congress not
later than January 15, 2012.33 Minutes of all negotiation meetings between FDA and industry
were required to be posted on the FDA website.

30 FFDCA 738(g).
31 Emphasis added. FFDCA 738(h)(2)(A)(ii). The law specifically defines “costs of resources allocated for the process
for the review of device applications” and what activities are considered part of the “process for the review of device
applications
.” For example, costs include management of information and activities associated with the process for
review include inspections of manufacturing establishments. [Emphasis added. FFDCA 737(8)-(9).] The process for
review of device applications focuses solely on activities involved in premarket approval, with one exception: the
evaluation of postmarket studies that are required as a condition of approval of certain premarket applications or
reports. [FFDCA 737(8)(J).]
32 FFDCA 738A(b)
33 FFDCA 738A(b)(5).
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MDUFA Impact on FDA Review Time and Budget
The amount of time it takes FDA to reach a review decision to clear a 510(k) notification or
approve a PMA application are measures of how well the agency is meeting the goals defined in
the MDUFA agreement between FDA and the medical device industry. The time it takes to review
a medical device—total review time—is composed of the time FDA handles the application—
FDA time—plus the amount of time the device sponsor or submitter requires to respond to
requests by FDA for additional information about the device.
According to CDRH Director Shuren, “FDA has been meeting or exceeding goals agreed to by
FDA and industry under MDUFA II for approximately 95% of the submissions we review each
year. For example, FDA completes at least 90% of 510(k) reviews within 90 days or less.”34
However, Dr. Shuren noted that these “metrics reflect FDA time only; they do not reflect the time
taken by device sponsors to respond to requests for additional information. Overall time to
decision—the time that FDA has the application, plus the time the manufacturer spends
answering any questions FDA may have—has increased steadily since 2001.”35
Figure 2 shows that while the amount of time FDA spends reviewing a 510(k) has decreased, the
average total days for the review of 510(k)s has been increasing. FDA and GAO have both
studied this issue of increasing review time. A 2011 FDA analysis of the reasons behind the
increased average total days for the review of 510(k)s found that FDA reviewers needed to ask for
additional information—called an AI Letter—from the 510(k) device manufacturer or sponsor
due to the poor quality of the original submission.36 According to FDA, these quality issues
involved “the device description, meaning the sponsor either did not provide sufficient
information about the device to determine what it was developed to do, or the device description
was inconsistent throughout the submission.”37

34 U.S. Congress, House Committee on Energy and Commerce, Subcommittee on Health, Reauthorization of MDUFA:
What it means for jobs, innovation and patients
, Statement of Jeffrey Shuren, CDRH Director, FDA, 112th Cong., 2nd
sess., February 15, 2012; and, U.S. Congress, Senate Committee on Health, Education, Labor and Pensions, FDA User
Fee Agreements
, Statement of Jeffrey Shuren, CDRH Director, FDA, 112th Cong., 2nd sess., March 29, 2012.
35 Ibid.
36 FDA/CDRH, Analysis of Premarket Review Times Under the 510(k) Program, July 2011, at http://www.fda.gov/
downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/UCM263386.pdf.
37 Ibid., p. 3. Page 15 of the 2011 FDA/CDRH 510(k) report provides more detail on these deficiencies: “(i) the sponsor
did not submit required information without justification – such information includes supporting data required under
current guidance or performance data that FDA consistently requires for certain device types; (ii) the sponsor failed to
identify a predicate; or (iii) the sponsor employed different device descriptions or indications for use for the subject
device throughout its submission. In all of these cases, FDA could not reach a substantial equivalence determination
without the sponsor providing additional information or rectifying deficiencies in the submission.”
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Figure 2. Average Time to Decision: 510(k)s
Fiscal Year Receipt Cohorts as of March 11, 2012

Source: Figure in testimony of CDRH Director Jeffrey Shuren before the Senate HELP Committee, March 29,
2012.
Notes: FDA Days + Submitter Days = Total Time to Decision; times may not add due to rounding. A cohort
consists of al 510(k) submissions filed in the same fiscal year. FY2008 through FY2011 cohorts are still open;
FY2011 cohort is only 85% closed, and average times will increase.
Furthermore, FDA concluded that “sponsors’ failure to address deficiencies identified in first-
round AI Letters are major contributors to the increase in total review times. For example, 65% of
the time FDA sent a second-round AI Letter because the sponsor failed to submit information
requested in the first AI Letter.”38 The 2011 FDA analysis also found “in some cases, the FDA
sent AI Letters for inappropriate reasons, such as asking for additional testing that was outside the
scope of what would be required for a 510(k) submission, or asking for supporting documentation
that was already covered by a standard government form.”39
GAO also performed an analysis of FDA performance goals regarding 510(k) device review
times and requests for additional information from sponsors.40 GAO found that although FDA
met all medical device performance goals for 510(k)s, the total review time—from submission to
final decision—has increased substantially in recent years. Regarding the agency’s use of AI
Letters, the GAO report notes that “the only alternative to requesting additional information is for

38 Ibid., p. 15.
39 Ibid., p. 7. Two separate analyses of AI Letters were conducted: one to assess incoming submission quality (Cohort
1) and one to assess the drivers of the increasing numbers of review cycles (Cohort 2). On page 3 of the July 2011
Analysis of Premarket Review Times Under the 510(k) Program report, FDA states that it analyzed AI letters “to
determine how often the questions that were asked were appropriate or inappropriate, i.e. were the AI Letters justified
or did the reviewer ask for information or data that were not permissible as a matter of federal law or FDA policy, or
unnecessary to make an SE [substantially equivalent] determination. Results from Cohort 1 showed that reviewers
asked for data that had not previously been requested for particular device types 12% of the time. Of those requests, 4%
were appropriate, and 8% were inappropriate. Results of the first-round AI Letters from Cohort 2 showed that
reviewers asked for appropriate data that had not previously been requested for particular device types 4% of the time,
and 2% of the time those requests were inappropriate.”
40 U.S. Government Accountability Office, Medical Devices: FDA Has Met Most Performance Goals but Device
Reviews Are Taking Longer
, GAO-12-418, February 2012, http://www.gao.gov/products/GAO-12-418.
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FDA to reject the submission.”41 Use of the AI Letter allows the sponsors the opportunity to
respond, and although the time to final decision is longer, the application has the opportunity to
be approved.
Figure 3 provides information on the amount of time FDA spends reviewing non-expedited PMA
applications and Panel-Track Supplements. A device may receive expedited review if it is
intended to treat or diagnose a life-threatening condition or irreversibly debilitating disease or
condition, and it addresses an unmet need.42 CDRH Director Shuren notes that although FDA is
spending less time reviewing PMA applications, the average total days for the review of PMA
applications has been increasing since 2004.43 The February 2012 GAO report found that for
FY2003 through FY2010, FDA met most of the goals for PMAs but fell short on most of the
goals for expedited PMAs.44 The February 2012 GAO report found that FDA review time and
time to final decision for both types of PMAs were highly variable but generally increased during
this period.45
Figure 3. Average Time to Decision: PMAs and Panel Track Supplements
(Non-expedited)

Source: Figure in testimony of CDRH Director Jeffrey Shuren before the Senate HELP Committee, March 29,
2012.
Notes: FDA Days + Submitter Days = Total Time to Decision; times may not add due to rounding. Data is for
non-expedited PMAs and Panel-Track Supplements. Some fiscal year cohorts are still open—data may change. A
cohort consists of all submissions of a certain type, in this case PMA, filed in the same fiscal year. For FY2010, as
of January 30, 2012, there were four applications without a decision; the average time to decision will increase as
the cohort closes.

41 Ibid., p. 16.
42 FDA Guidance, Expedited Review of Premarket Submissions for Devices, February 29, 2008, p. 3, at
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089698.pdf.
43 U.S. Congress, House Committee on Energy and Commerce, Subcommittee on Health, Reauthorization of MDUFA:
What it means for jobs, innovation and patients
, Statement of Jeffrey Shuren, CDRH Director, FDA, 112th Cong., 2nd
sess., February 15, 2012; and, Senate Committee on Health, Education, Labor and Pensions, FDA User Fee
Agreements
, Statement of Jeffrey Shuren, CDRH Director, FDA, 112th Cong., 2nd sess., March 29, 2012.
44 Ibid., p. 20.
45 U.S. Government Accountability Office, Medical Devices: FDA Has Met Most Performance Goals but Device
Reviews Are Taking Longer
, GAO-12-418, February 2012, p. 20, http://www.gao.gov/products/GAO-12-418.
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The February 2012 GAO report also commented on communication problems between industry
and FDA based on interviews with three industry groups about the medical device review
process. These industry representatives noted that FDA “guidance documents are often unclear,
out of date, and not comprehensive.”46 They also stated that “after sponsors submit their
applications to FDA, insufficient communication from FDA prevents sponsors from learning
about deficiencies in their submissions early in FDA’s review. According to one of these
stakeholders, if FDA communicated these deficiencies earlier in the process, sponsors would be
able to correct them and would be less likely to receive a request for additional information.”47
Two industry representatives noted that “review criteria sometimes change after a sponsor
submits an application,” and one industry representative stated that “criteria sometimes change
when the FDA reviewer assigned to the submission changes during the review.”48 The February
2012 GAO report points out that FDA has taken a number of actions to address the issues of the
industry representative. For example, FDA has issued new guidance documents, improved the
guidance development process, initiated a reviewer certification program for new FDA reviewers,
and enhanced its interactive review process for medical devices.
For FY2012, 36% of FDA’s total budget comes from user fees.49 Medical device user fee revenue
provides about 10% of the FDA medical device and radiological health program budget.50 Figure
4
presents the total program level for FDA’s device and radiological health program for FY2002
through FY2013 with dollars adjusted for inflation (based on 2005 dollars). Figure 4 also shows
the contribution of medical device user fees, which began in FY2003, to the device and
radiological health program budget, as well as fees collected for the inspection of mammography
facilities under the Mammography Quality Standards Act (MQSA), which began fee collection in
FY1996. For FY2010, user fees collected under MDUFA funded about 20% of the device review
program, while user fees collected under PDUFA funded over 60% of the drug review program.

46 Ibid., p. 34.
47 Ibid.
48 Ibid., p. 35.
49 In addition to medical device user fees, Congress has authorized user fees for prescription drugs, animal drugs,
animal generic drugs, tobacco products, mammography, color and export certification, and, most recently, several food-
related programs.
50 Of the $57.6 million in medical device user fees for FY2012, 60% goes to the devices and radiological health
program (funding 221 full-time equivalent employees [FTEs]), 20% to the biologics program (29 FTEs), and the
remaining 20% to rent and FDA headquarters (21 FTEs). Data from Department of Health and Human Services (HHS),
Fiscal Year 2013 Food and Drug Administration: Justification of Estimates for Appropriations Committees, February
2012, p. 94.
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Figure 4. Devices and Radiological Health Program Budget, by Funding Source, for
FY2002 to FY2013
(Adjusted to 2005 dol ars)

Source: FDA Justification of Estimates for Appropriations Committees documents, FY2004 through FY2013.
*Only total user fees were available for FY2004; amounts for medical device user fees and MQSA fees were not
identified in the FY2006 Justification of Estimates for Appropriations Committees. See Table 1.
Notes: Total Program Level = Budget Authority + Medical Device User Fees + MQSA Fees. Data have been
adjusted to constant 2005 dol ars using “Total Non-Defense” deflators from Office of Management and Budget,
Fiscal Year 2013 Historical Tables, Budget of the U.S. Government, “Table 10.1, Gross Domestic Product and
Deflators Used in the Historical Tables: 1940-2017,” pp. 211-212.
User fees are an increasing proportion of FDA’s device-related budget, as shown in Table 1. User
fees are 7.1% of FDA’s devices and radiological health program level budget in FY2002 when
MQSA was the sole user fee, and 14.2% of FDA’s devices and radiological health program level
budget in FY2012, with both MQSA and medical device user fees being collected by the agency.
Table 1 shows that over the period of FY2003 to FY2012, the amount of user fees more than
doubled, while the amount of direct appropriations (budget authority) increased at a slower rate.
Table 1. FDA Devices and Radiological Health Program, Fees as a Percentage of Total
Program Level
(Unadjusted dollars in millions)
Total Fees
as % of
Total
Total
Budget
MDUFAa
MQSAb and
Program
Program
Fiscal Year
Authority
Fees
Other Feesc
Total Fees
Level
Level
2002 $180.0
$0
$13.7
$13.7
7.1%
$193.7
2003
$193.4 $11.1 $12.9 $24.0 11.0% $217.3
2004d $191.1
na
na
$30.4
13.7%
$221.5
2005
$215.0 $16.4 $13.0 $29.3 12.0% $244.3
2006
$220.6 $20.7 $13.8 $34.5 13.5% $255.0
2007
$230.7 $23.3 $13.6 $36.9 13.8% $267.5
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Total Fees
as % of
Total
Total
Budget
MDUFAa
MQSAb and
Program
Program
Fiscal Year
Authority
Fees
Other Feesc Total
Fees
Level
Level
2008
$237.7 $24.3 $13.3 $37.6 13.7% $275.3
2009
$298.5 $33.3 $13.5 $46.8 13.6% $345.3
2010
$313.5 $42.7 $13.8 $56.5 15.3% $370.0
2011
$322.2 $42.0 $14.4 $56.3 14.9% $378.5
2012
$322.7 $34.2 $19.1 $53.3 14.2% $376.0
2013
$319.1 $41.4 $26.3 $67.6 17.5% $386.8
Source: FDA Justification of Estimates for Appropriations Committees documents, FY2004 through FY2013,
a. MDUFA is Medical Device User Fee Act.
b. MQSA is Mammography Quality Standards Act.
c. For FY2013, the Obama Administration proposes a new Field Reinspection fee and a new International
Courier User Fee.
d. The FY2006 Justification organized data, including Actual data for FY2004, in a format different than other
Justification documents (it included rent but did not include the Office of Regulatory Affairs). The FY2007
and FY2008 Justification documents provided data in consistent format (without rent but included ORA) for
FY2004 Budget Authority, Total Fees, and Total Program Level, but did not provide medical device user
fees or MQSA amounts. The FY2006 Justification provided the fol owing amounts for Actual FY2004 user
fees: medical device user fees, $18.245 million; MQSA, $4.039 million; ORA user fees, $9.071 million.
MDUFA III Proposal
An initial public meeting on the reauthorization of the medical device user fees was held by FDA
on September 14, 2010, after which the negotiation process between FDA and industry began, as
well as monthly meetings with other stakeholders.51 Minutes of the 35 negotiation meetings
between FDA and the medical device industry are posted on the agency’s website, as are minutes
of the 14 monthly meetings with the other stakeholders, such as health care professional
associations and patient and consumer advocacy groups.52
On February 1, 2012, FDA announced that it had reached “an agreement in principle on proposed
recommendations for the third reauthorization of a medical device user fee program.”53 According
to a press release on the FDA website, the recommendations would authorize $595 million in user
fees collected by the agency from the medical device industry over a five-year period.54 FDA
would be able to hire more than 200 full-time-equivalent workers with this additional funding. In
the minutes for the January 31, 2012, negotiation meeting, industry noted “that MDUFA III

51 FDA, Public Workshop: Medical Device User Fee Program Public Meeting, September 14, 2010, at
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm218250.htm.
52 FDA, Medical Devices, MDUFA Meetings at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm236902.htm.
53 Food and Drug Administration, “FDA and Industry reach agreement in principle on medical device user fees,” press
release, February 1, 2012, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm289828.htm.
54 Ibid.
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represents a sizeable increase of 240 FTEs from current levels, FDA should not expect this type
of significant resource increase under MDUFA IV.”55 In response, the agency stated that it had
“some concerns about how solid a financial footing this agreement establishes, given that there
are a lot of uncertainties about how much effort will be required to meet the goals, and that in
order to bring the proposal to a level that Industry could agree to, FDA had to take away any
margin of error.”56
On March 14, 2012, the agency posted on its website the draft negotiated package—composed of
statutory language and the FDA-industry agreement on performance goals and procedures—
referred to as MDUFA III.57 A public meeting describing the draft was held on March 28, 2012.
The 30-day comment period on the draft ended April 16, 2012. Following review of the
comments, FDA may revise the recommendation and then is to submit the final package to
Congress.
Tables in the appendixes provide additional details on the draft MDUFA III proposal beyond the
narrative discussion found below. The tables in Appendix A relate to the legislative language and
the table in Appendix B relates to the FDA-industry agreement on performance goals and
procedures.
Draft Legislative Language
The draft legislative language portion of the MDUFA III proposal would change the definition of
“establishment subject to a registration fee,” increasing the number of establishments paying the
fee from 16,000 to about 22,000.58 It would set the fee amount for a PMA in FY2013 at $248,000.
The fee amount for a PMA would gradually rise to $268,443 for FY2017. The establishment fee
would be $2,575 in FY2013 and rise to $3,872 for FY2016 and FY2017. Other than the
establishment fee, the amount of each type of user fee is set as a percentage of the PMA fee, also
called the base fee. The draft proposal would keep the percentages the same as in current law
except for the 510(k) fee which would change from 1.84% of the PMA fee to 2% of the PMA fee.
Total fee revenue would be set at $97,722,301 for FY2013 and rise to $130,184,348 for FY2017.
The total fees collected over the five-year period FY2013 through FY2017 would be $595
million.
The draft MDUFA III legislative language would adjust the total revenue amounts by a specified
inflation adjustment, similar to the adjustment made under PDUFA, and the base fee amount
would be adjusted as needed on a uniform proportional basis to generate the inflation-adjusted
total revenue amount. After the base fee amounts are adjusted for inflation, the establishment fee
amount would be further adjusted as necessary so that the total fee collections for the fiscal year

55 FDA, Minutes From Negotiation Meeting on MDUFA III Reauthorization, January 31, 2012, at http://www.fda.gov/
MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/
ucm289824.htm.
56 Ibid.
57 FDA, draft statutory language dated February 17, 2012, and posted at http://www.fda.gov/downloads/
MedicalDevices/NewsEvents/WorkshopsConferences/UCM295424.pdf . FDA, “Draft MDUFA III Commitment
Letter,” dated February 17, 2012, and posted on FDA website March 14, 2012, at http://www.fda.gov/downloads/
MedicalDevices/NewsEvents/WorkshopsConferences/UCM295454.pdf. Document is referred to, at times, as the
Commitment Letter or the Agreement.
58 FDA, MDUFA Reauthorization Public Meeting, March 28, 2012.
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would generate the total adjusted revenue amount. The new adjusted fee amounts would be
published in the Federal Register 60 days before the start of each fiscal year along with the
rationale for adjusting the fee amounts.
The draft legislative language includes a provision that would allow FDA to grant a waiver or
reduce fees for a PMA or establishment fee “if the waiver is in the interest of public health.”
According to the FDA presentation at the March 28, 2012, public meeting, the fee waiver is
intended for laboratory developed test (LDT) manufacturers. This provision would sunset at the
end of MDUFA III.
The draft proposal includes a requirement that sponsors submit an electronic copy of a PMA,
510(k), and other specified submissions and any supplements to such submissions. The
requirement would begin after the issuance of final guidance. The draft legislative language also
includes a provision for streamlined hiring of FDA employees. The authority for streamlined
hiring would terminate three years after enactment.
Draft Industry-FDA Performance Goals and Procedures for
MDUFA III: The Agreement

The agreement begins by stating, “FDA and the industry are committed to protecting and
promoting public health by providing timely access to safe and effective medical devices.
Nothing in this letter precludes the Agency from protecting the public health by exercising its
authority to provide a reasonable assurance of the safety and effectiveness of medical devices.”59
The agreement subsequently describes a number of process improvements that aim to improve
FDA’s medical device review process, provides revised performance goals and new shared
outcome goals, describes infrastructure improvements, and provides for an independent
assessment of the device review process.
Process Improvements. In comparison to MDUFA II, the discussion of these topics is greatly
expanded and consolidated into one new section of the agreement. FDA will put in place a
structured process for managing pre-submissions, providing feedback to applicants via e-mail and
a one-hour meeting or teleconference. It will publish guidance on electronic submissions and will
clarify submission acceptance criteria. The agency will continue to use interactive review to
encourage informal communication with the applicant to facilitate timely completion of the
review process. FDA will continue to apply user fees to the guidance document development
process, and may apply user fees to delete outdated guidance, note which are under review, and
provide a list of prioritized device guidance documents intended to be published within a year. It
will work with interested parties to improve the current third-party review program. FDA will
implement final guidance on factors to consider when making benefit-risk determinations in
device premarket review, including patient tolerance for risk and magnitude of benefit. The
agency will propose additional low-risk medical devices to exempt from the 510(k) process. FDA
will work with industry to develop a transitional in vitro diagnostics (IVD) approach for the
regulation of emerging diagnostics.

59 FDA, “Draft MDUFA III Commitment Letter,” dated February 17, 2012, and posted on FDA website March 14,
2012, at http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM295454.pdf.
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Review Performance Goals. The main focus of the agreement is FDA’s commitment to
completing the review of the various medical device submissions—such as PMA reviews and
510(k) notifications—within specified timeframes in exchange for an industry fee to support the
review activity. Performance goals are specified for each type of submission and for FY2013
through FY2017; each goal specifies the percentage of applications FDA will complete along
with a given time period. See Table B-1 and Table D-1 for further details.
Shared Outcome Goals. This is a new section and was not part of the MDUFA II agreement. The
purpose of the programs and initiatives outlined in the agreement is to reduce the average total
time to decision for PMAs and 510(k)s. FDA and applicants share the responsibility for achieving
this goal. For PMA submissions received beginning in FY2013, the average total time to decision
goal for FDA and industry is 395 calendar days; beginning in FY2015, 390 calendar days; and
beginning in FY2017, 385 calendar days. For 510(k) submissions received beginning in FY2013,
the average total time to decision goal for FDA and industry is 135 calendar days; beginning in
FY2015, 130 calendar days; and beginning in FY2017, 124 calendar days.
Infrastructure. User fees will be used to “reduce the ratio of review staff to front line supervisors
in the Pre-market review program.”60 FDA will enhance and supplement scientific review
capacity by hiring reviewers and using external experts to assist with device application review.
FDA will seek to obtain streamlined hiring authority and work with industry to benchmark best
practices for employee retention via financial and non-financial means. User fees will supplement
(1) management training; (2) MDUFA III training for all staff; (3) Reviewer Certification
Program for new CDRH reviewers; and (4) specialized training to provide continuous learning
for all staff. FDA will improve its IT system to allow real-time status information on submissions.
Independent Assessment of Review Process Management. By the end of the second quarter of
FY2013, FDA will hire a consultant to assess the device application review process. Within six
months of award of the contract, a report on recommendations likely to have a significant impact
on review time will be published. The final report will be published within one year of contract
award date. FDA will publish a corrective action and implementation plan within six months of
receipt of each report. The consultant will evaluate FDA’s implementation and publish a report no
later than February 1, 2016.
Performance Reports. As was the case in MDUFA II, FDA will meet with industry on a
quarterly basis to present data and discuss progress in meeting goals. The agreement requires
more detailed information to be covered in quarterly reports by CDRH and CBER; specifically,
elements to be included are listed for 510(k)s, PMAs, Pre-Submissions, and Investigational
Device Exemptions (IDEs).61 CDRH reports quarterly and CBER reports annually on 11
additional data points. FDA reports annually on nine other topics.
Discretionary Waiver. FDA will seek authority to grant discretionary fee waivers or reduced fees
in the interest of public health. Authority for the waiver and reduced fees would expire at the end
of MDUFA III. According to the FDA presentation at the March 28, 2012, public meeting, the fee
waiver is intended for laboratory developed test (LDT) manufacturers.

60 Ibid., p. 12.
61 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.
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Other Potential Issues
In addition to MDUFA III, Congress is considering reauthorization of PDUFA as well as new
proposals for a Generic Drug User Fee Act and a Biosimilars User Fee Act. It is likely that these
three will be combined with MDUFA III along with a variety of related and unrelated issues.
Because of the importance of user fees to FDA’s budget, PDUFA and MDUFA are considered to
be “must pass” legislation, and Congress has often in the past included language to address a
range of other concerns. For example, MDUFA II included provisions about the extent to which
FDA can delegate activities to third parties (inspections and the review of premarket
notifications); establishment registration requirements (timing and electronic submission); a
unique device identification system; and reporting requirements for devices linked to serious
injuries or deaths. Provisions that have been mentioned as possibly being included in current
legislation containing FDA user fee authorization include the following:
• reauthorization of Best Pharmaceutical for Children Act (BPCA) and Pediatric
Research Equity Act (PREA);
• provisions to prevent, avert, or manage drug shortages;
• incentives for antibiotic makers;
• security of the pharmaceutical supply chain;
• less restrictive FDA advisory committee conflict-of-interest waiver policies;
• parity for foreign and domestic manufacturing inspections;
• quicker approval of drugs to treat very rare diseases;
• increased input from patients, hospitals, pharmacists, and others in drug
development, review, and postmarket study;
• recall authority for drug products;
• personal-use and commercial drug importation;
• clarification of the least burdensome standard in requesting additional
information from sponsors of PMA or 510(k) submissions;
• expanding FDA’s authority to require a manufacturer to conduct postmarket
surveillance of class II and class III medical devices;
• inclusion of medical devices in the Sentinel Initiative/System;62
• extension of the humanitarian device exemption;
• continuation of a demonstration grant program on improving the availability of
pediatric devices;
• extension of the third-party review program for 510(k) submissions; and
• limiting the use of a recalled medical device as a predicate in 510(k) submissions.

62 A national electronic system under development that would transform FDA’s ability to track the safety of drugs,
biologics, and medical devices once they reach the market. FDA launched the Sentinel Initiative in May 2008; once
completed, it would be called the Sentinel System. For more information, see http://www.fda.gov/safety/
FDAsSentinelInitiative/ucm2007250.htm.
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The House Committee on Energy and Commerce, Subcommittee on Health held a hearing on
MDUFA on February 15, 2012, and the Senate Committee on Health, Education, Labor and
Pensions held a hearing on FDA user fee agreements on March 29, 2012. The hearing testimony
submitted to both the House and Senate by CDRH Director Jeffrey Shuren stated that in FY2010,
user fee revenue funded about 20% of the medical device premarket review process; fees
collected under MDUFA III would fund about a third of the medical device premarket review
process.63 In contrast, fees collected under PDUFA in FY2010 covered more than 60% of drug
review costs. In response to questioning at the Senate hearing, CDRH Director Shuren said if
MDUFA reauthorization by Congress has not occurred by early summer, federal regulations
require that reduction in force (RIF) notices be sent out in July 2012, giving 60 days’ advance
notice to about 250 FDA employees that their employment under the MDUFA program would
end by September 30, 2012.
The House and Senate committees are circulating discussion drafts that contain many of the
above listed provisions.64 CDRH Director Shuren has indicated that some of these pending
reforms could conflict with what the agency has negotiated with industry in the MDUFA III
proposal. “There are several provisions that could have an impact, that could divert resources
from implementation of the MDUFA goals and/or that go to issues that were discussed as a part
of MDUFA ... that would be counter and would reopen those discussions,” according to CDRH
Director Shuren.65 He indicated that proposals regarding device tracking, guidance development,
and third-party reviews were of concern, but that “there are many others ... particularly in the
House bill.”66 Some proposals are of concern because they would require more agency resources;
other proposals were discussed during the user fee negotiations with industry and “taken off the
table.”67

63 U.S. Congress, House Committee on Energy and Commerce, Subcommittee on Health, Reauthorization of MDUFA:
What it means for jobs, innovation and patients
, Statement of Jeffrey Shuren, CDRH Director, FDA, 112th Cong., 2nd
sess., February 15, 2012; and, U.S. Congress, Senate Committee on Health, Education, Labor and Pensions, FDA User
Fee Agreements
, Statement of Jeffrey Shuren, CDRH Director, FDA, 112th Cong., 2nd sess., March 29, 2012.
64 The draft Senate bill that contains provisions related to the regulation of medical devices can be found at
http://www.help.senate.gov/imo/media/audio/031612_Device_DRAFT_TAM12069.pdf. The draft House bill
containing both drug and medical device regulation can be found at http://insidehealthpolicy.com/iwpfile.html?file=
mar2012%2Fhe03132012_fee.pdf.
65 Alaina Busch, “FDA Official: Guidance, Tracking Among Device Bills Clashing With Fee Pact,”
InsideHealthPolicy.com, March 28, 2012.
66 Ibid.
67 Ibid.
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Appendix A. Provisions in FFDCA §737 and §738
Table A-1. Provisions in Section 737 and 738 of the Federal Food, Drug, and
Cosmetic Act Relating to Medical Device User Fees
MDUFA III Statutory
Language that HHS
Main Issue
Current Law
Submitted to Congress
Section 737. Definitions.
Definitions
Provides definitions for a number of terms.
Would update the definition of
“adjustment factor” and change
the definition of “establishment
subject to a registration fee,”
increasing the number paying
the fee from 16,000 to 22,000.
Section 738. Authority to Assess and Use Device Fees.
(a)(1)
There are several types of fees and certain exceptions to the

Types of fees
col ection of such fees.
(a)(2)(A)
A fee is assessed for:

PMA,
premarket
premarket application (PMA)

report,
premarket report, equal to the PMA fee

supplement,
panel track supplement, 75% of the PMA fee
and
180-day supplement, 15% of the PMA fee

submission
real-time supplement, 7% of the PMA fee

fee, and
30-day notice, 1.6% of the PMA fee
annual fee for
efficacy supplement, equal to the PMA fee
Would set fee for 510(k) at 2%
periodic
premarket notification submission [510(k)], 1.84% of the PMA fee
of the PMA fee
reporting
request for classification information, 1.35% of the PMA fee
concerning a
periodic reporting concerning class III device, 3.5% of PMA fee.
class III device

(a)(2)(B)
Exceptions are made for humanitarian device exemption, PMA

Exceptions
for a biologic product licensed for further manufacturing use only,
devices sponsored by state or federal government and not
intended for commercial distribution, 510(k) reviewed by an
accredited third party, and PMAs, premarket reports and 510(k)s
if the device is intended solely for a pediatric population, as well
as supplements proposing conditions of use for a pediatric
population.
(a)(2)(C)(D)
The fee is due at the time of submission.

Payment,
Refund
Partial or full refunds of fees either may or must occur, depending
on certain conditions.
(a)(3) Annual
An establishment registration fee is assessed annually. Exceptions
Would make technical change
establishment
are made for an establishment operated by state or federal
to date payable.
registration
government entity, and Indian tribes unless the device is intended
fee
for commercial distribution.
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The FDA Medical Device User Fee Program

MDUFA III Statutory
Language that HHS
Main Issue
Current Law
Submitted to Congress
(b) Fee
Fees are based on the fol owing amounts which may be adjusted
New (b)(1)-(2). Would change
amounts
by the Secretary for various reasons:
fee amounts and change
reasons for adjustment:
PMA
Establishment
FY2008 $185,000
$1,706
PMA
Establish.
FY2009 $200,725
$1,851
FY2013: $248,000;
$2,575
FY2010 $217,787
$2,008
FY2014: $252,960;
$3,200
FY2011 $236,298
$2,179
FY2015: $258,019;
$3,750
FY2012 $256,384
$2,364
FY2016: $263,180;
$3,872
FY2017: $268,443;
$3,872
(h) Crediting
FY2008 $48,431,000
[FY2013 $95,429,314]
Total revenue amounts, new
and
FY2009 $52,547,000 [FY2014 $112,171,877]
(b)(3). Would set total fee
availability of
FY2010 $57,014,000 [FY2015 $127,537,959]
revenue amounts as follows:
fees
FY2011 $61,860,000 [FY2016 $129,997,509]
FY2013 $97,722,301
FY2012 $67,118,000 [FY2017 $130,328,967]
FY2014 $112,580,497
FY2015 $125,767,107
Bracketed amounts in proposal, not current law.
FY2016 $129,339,949
FY2017 $130,184,348.
(c)(1)
The Secretary publishes fee amounts in the Federal Register 60
Secretary would, 60 days
Annual fee
days before the start of each fiscal year.
before the start of each fiscal
setting; in
year, establish fees based on
general

amounts specified in subsection
(b) and the adjustments in this
subsection, and publish such
fees and rationale for adjusting
fee amounts in the Federal
Register.
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MDUFA III Statutory
Language that HHS
Main Issue
Current Law
Submitted to Congress
(c)(2)
The Secretary may increase the establishment fee for FY2010
Inflation adjustment. Would
Adjustment
only if the estimate of number of establishments submitting fees
adjust total revenue amounts
for FY2009 is less than 12,250. If the fee for FY2010 is adjusted,
by a specified inflation
fees for FY2011 and FY2012 may be increased by 8.5% over the
adjustment based on the sum
previous year. The determination and its rationale must be
of one plus—the average
published in the Federal Register.
annual change in the cost per
FTE position at FDA of al
personnel compensation and
benefits paid for the first 3
years of the preceding 4 fiscal
years, multiplied by 0.60, and
the average annual change in
the Consumer Price Index
(Metro DC, Baltimore, WV.
not seasonally adjusted, all
items, annual index) for the
first 3 years of the preceding 4
years of available data
multiplied by 0.40. If the sum is
less than 1, the sum is
considered to be 1; or greater
than 1.04, the sum is
considered to be 1.04. The
base fee amounts in new
subsection (b)(2) would be
adjusted as needed on a
uniform proportional basis to
generate the inflation adjusted
total revenue amount.
Adjustment
No provision.
New (c)(3). For each fiscal
to
year, after the base fee
establishment
amounts in new subsection
registration
(b)(2) are adjusted for inflation,
base fees
the base establishment
registration fee amounts would
be further adjusted as
necessary for total fee
col ections for the fiscal year to
generate the total adjusted
revenue amount.
(c)(3)
For each fiscal year, the total amount of fees, as adjusted, may not Now (c)(4)
Limit
exceed the total costs for the resources allocated for the process
for the review of device applications.
(c)(4)
Secretary may use unobligated carryover balances from fees
Now (c)(5)
Supplement
col ected in previous years to ensure sufficient fee revenues are
available, so long as there is a certain operating reserve. Not later
than 14 days before using these funds, the Secretary must provide
notice to House and Senate Appropriation Committees, Senate
HELP and House Energy and Commerce Committees.
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MDUFA III Statutory
Language that HHS
Main Issue
Current Law
Submitted to Congress
(d)(e)
Secretary may waive the fee for the first premarket review or

Small
first premarket report of a product submitted by a smal business,
businesses;
defined as an entity that reported less than $30 million in gross
fee waiver
receipts or sales in its most recent federal income tax return.
and fee
reduction
If a device company has annual gross receipts or sales of $100
million or less in the most recent federal income tax return for a
taxable year, including returns of its affiliates, the device
manufacturer is a small business eligible for 75% reduction in fees
for PMAs, premarket reports, supplements, and periodic
reporting concerning class III devices. Such a device manufacturer
is also considered a small business eligible for a reduced rate of
50% for fees regarding 510(k)s, 30-day notices and requests for
classification information. Proof of gross sales or receipts may
consist of IRS tax documents or qualifying documentation from
the taxing authority of the foreign country in which the applicant
or affiliate is headquartered.
Fee waiver or
No provision.
Would allow the Secretary to
reduction
grant a waiver or reduced fees
for a PMA or establishment fee
if the waiver is in the interest
of public health. Waivers & fee
reductions must be less than
2% of total fee revenue for that
year. Authority for the waiver
and reduced fees ends on
October 1, 2017.
(f) Effect of
PMAs, 510(k), requests for classification, and other submissions

failure to pay
for which fees apply will not be accepted if fees are not paid.
fees
(g)
Direct appropriations must be more than 1% less than
Changes amount to
Conditions
$205,720,000 multiplied by an adjustment factor, or else the
$280,587,000.
(Trigger)
Secretary may not col ect user fees and is not required to meet
performance goals.
(h)
The fol owing amounts of user fees are authorized to be
Would add provision al owing
Crediting and
appropriated:
the Secretary to accept early
availability of
FY2008 $48,431,000
payment of authorized fees.
fees
FY2009 $52,547,000
Would authorize to be
FY2010 $57,014,000
appropriated for FY2013
FY2011 $61,860,000
through FY2017 fees equal to
FY2012 $67,118,000
the total revenue amount as
Offset is handled as fol ows: the amount of fees col ected, in the
specified under new
first three fiscal years and estimated for the fourth fiscal year, in
subsection(b)(3), as adjusted
excess of the amount specified in appropriations acts is credited
for inflation and offset.
to FDA’s appropriation account, and the excess subtracted from
the amount that would otherwise have been authorized to be
col ected during the fifth fiscal year.
(i)
Any unpaid fee shall be treated as a claim of the United States

Collection of
Government.
unpaid fees
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The FDA Medical Device User Fee Program

MDUFA III Statutory
Language that HHS
Main Issue
Current Law
Submitted to Congress
(j)
A sponsor must submit a written request to the Secretary for a

Written
refund not later than 180 days after the fee is due.
requests for
refunds
(k)
“This section may not be construed to require that” HHS reduce

Construction
FTE positions of officers, employees, and advisory committee
members in other areas to offset those “engaged in the process
of the review of device applications.”
Sources: FFDCA §§737-738 (21 U.S.C. §§379i-379j); and FDA, “Draft MDUFA III Legislative Language,” dated
February 17, 2012, posted on FDA website March 14, 2012, at http://www.fda.gov/downloads/MedicalDevices/
NewsEvents/WorkshopsConferences/UCM295424.pdf.
Note: Paragraph and subparagraph labeling follows current law.

Table A-2. Provisions in Draft MDUFA III Legislative Language That Would Add Two
New Sections to Chapter VII of the Federal Food, Drug, and Cosmetic Act
Main Issue
Provision Included in Draft MDUFA Legislation
Subchapter D—Information and Would require that after final guidance is issued, PMA, 510(k), Product
Education
Development Protocol, Investigational Device Exemption (IDE), Humanitarian
Sec. 74x
Device Exemption (HDE), and other specified pre- submissions and submissions,
and any supplements to such submissions must include an electronic copy.
Subchapter A—General
Would allow the Secretary, without regard to provisions in title 5 U.S.C., to
Administrative Provisions
appoint employees to appoint FDA employees to positions related to the process
Sec. 7xx
for the review of device applications in order to achieve the performance goals
Streamlined hiring authority
referred to in section 738A(a)(1) as set forth in the Secretary’s Commitment
Letter. The authority to appoint such employees would terminate three years
after the date of enactment.
Source: FDA, “Draft MDUFA III Legislative Language,” dated February 17, 2012, posted on FDA website March
14, 2012, at http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/
UCM295424.pdf.

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Appendix B. MDUFA III Agreement: Performance
Goals and Procedures

Table B-1. Performance Goals and Procedures in Agreement
Between FDA and Industry Representatives for FY2013 through FY2017
Under the Draft MDUFA III
Similar language in
MDUFA II
Topic
Draft MDUFA III commitments
commitments
I. Process
Pre-Submissions. FDA wil issue draft guidance and final guidance on a
FDA wil make every
Improvements
new structured process for managing Pre-Submissions. Upon receipt of a
effort to schedule both
Pre-Submission, FDA intends to schedule a one hour meeting or
informal and formal
teleconference, if requested. Within 14 days of receipt, FDA will
meetings, both before
determine if the Pre-Submission meets the definition and notify the
and during the review
applicant if it does not. Three business days prior to meeting, FDA will
process, in a timely
provide initial feedback via email. FDA and applicant may cancel meeting
manner. These
if no longer needed based on email that will serve as final written
meetings include pre-
feedback. Within 15 days, applicant provides draft minutes including
submission meetings.
agreements and action items, and FDA edits minutes which become final
15 days after received by applicant. FDA feedback is intended to be final,
unless FDA concludes that the feedback does not address important new
safety and effectiveness issues.
Submission Acceptance Criteria. Prior to implementation, FDA wil
New section.
publish draft and final guidance on electronic submissions and objective
criteria for revised “refuse to accept/refuse to file” checklists.
Interactive Review. As described in current guidance, FDA will continue
FDA will continue to
to use interactive review to encourage informal communication between
use interactive review
agency and applicant to facilitate timely completion of the review
process to encourage
process.
communication and
facilitate review.
Guidance Document Development. FDA will apply user fees to the
FDA will develop
guidance document development process, but not to the detriment of
guidance documents to
meeting the quantitative review timelines and statutory obligations. FDA
the extent possible
will update its website, deleting outdated guidance, noting which are
without impacting
under review, and providing a list of prioritized device guidance
device review time and
documents intended to be published within 12 months and other device
will post guidance
guidance documents intended to be published as resources permit.
under development for
comment.
Third Party Review. FDA wil work with interested parties to improve

the current program and transparency, but not to the detriment of
meeting the quantitative review timelines and statutory obligations.
Patient Safety and Risk Tolerance. FDA wil fully implement final guidance New section.
on factors to consider when making benefit-risk determinations in device
premarket review, including patient tolerance for risk, magnitude of
benefit, and availability of other treatments or diagnostic tests.
Low Risk Medical Device Exemptions. By the end of FY2013, FDA will
New section.
propose additional low risk medical devices to exempt from the 510(k)
process and intends to issue a final rule within 2 years exempting
additional low risk devices from 510(k).
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Similar language in
MDUFA II
Topic
Draft MDUFA III commitments
commitments
Emerging Diagnostics. FDA will work with industry to develop a
To facilitate IVD
transitional in vitro diagnostics (IVD) approach for the regulation of
development, FDA will
emerging diagnostics.
explore ways to clarify
the regulatory
requirements by issuing
guidance as well as 5
other specified
activities.
II. Review
PMA, Panel-Track Supplements, and Premarket Report Applications.
FDA wil issue a
performance goals
Performance goals apply to al PMAs, Panel-Track Supplements, and
decision for 60% of
Premarket Report Applications including those that are priority review
non-expedited filed
(previously referred to as expedited). FDA wil communicate with
submissions within 180
applicant on status of application within 15 days of receipt. For
days, and for 90%
submissions that do not require Advisory Committee input, FDA will
within 295 days. FDA
issue a MDUFA decision within 180 FDA Days for: 70% of submissions
will issue a decision for
received in FY 2013; 80% of submissions received in FY 2014 and FY
50% of expedited filed
2015; and 90% of submissions received in FY 2016 and FY 2017. For
submissions within 180
submissions that require Advisory Committee input, FDA will issue a
days and for 90% within
MDUFA decision within 320 FDA Days for: 50% of submissions received
280 days.
in FY 2013; 70% of submissions received in FY 2014; 80% of submissions
received in FY 2015 and FY 2016; and 90% of submissions received in FY
2017. For al PMAs that do not reach a MDUFA decision by 20 days after
the FDA Day goal, FDA will provide written feedback to the applicant
including all outstanding issues preventing FDA from reaching a decision.
180-Day PMA Supplements. FDA will communicate with applicant within
FDA wil issue a
90 days of receipt of the submission for: 65% of submissions received in
decision for 85%
FY 2013; 75% of submissions received in FY 2014; 85% of submissions
within 180 days and for
received in FY 2015; and 95% of submissions received in FY 2016
95% within 210 days.
through FY 2017. FDA will issue a MDUFA decision within 180 FDA
Days for: 85% of submissions received in FY 2013; 90% of submissions
received in FY 2014 and FY 2015; and 95% of submissions received in FY
2016 through FY 2017.
Real-Time PMA Supplements. FDA will issue a MDUFA decision within
FDA wil issue a
90 FDA Days for: 90% of such submissions received in FY 2013 and FY
decision for 80% within
2014; and 95% of such submissions received in FY 2015 through FY
60 days, and for 90%
2017.
within 90 days.
510(k) Submissions. FDA will communicate with applicant on status of
FDA wil issue a
application within 15 days of receipt. For submissions received in FY
decision for 90% of
2013, FDA will issue a MDUFA decision for 91% of 510(k) submissions
510(k)s within 90 days,
within 90 FDA Days. For submissions received in FY 2014, FDA will
and for 98% within 150
issue a MDUFA decision for 93% of 510(k) submissions within 90 FDA
days.
Days. For submissions received in FY 2015 through FY 2017, FDA will
issue a MDUFA decision for 95% of 510(k) submissions within 90 FDA
Days. For al 510(k)s that do not reach a MDUFA decision within 100
FDA Days, FDA will provide written feedback to the applicant including
al outstanding issues preventing FDA from reaching a decision.
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Similar language in
MDUFA II
Topic
Draft MDUFA III commitments
commitments
CLIA Waiver by Application. During the pre-submission process, if the
New section.
applicant informs FDA that it plans to submit a dual submission (510(k)
and CLIA Waiver application), FDA will issue a decision for 90% of such
applications within 210 FDA days. For “CLIA Waiver by Application”
submissions FDA will issue a MDUFA decision: for 95% of the
applications that do not require Advisory Committee input within 180
FDA days; for 95% of the applications that require Advisory Committee
input within 330 FDA days. FDA will issue guidance regarding review and
management expectations to provide greater transparency throughout
the entire submission process.

Biologics Licensing Applications (BLAs). FDA will review and act on
90% of BLAs in 10
standard original BLA submissions within 10 months of receipt for 90%
months.
of submissions. FDA will review and act on priority original BLA
submissions within 6 months of receipt for 90% of submissions. FDA will
90% of BLA
review and act on standard BLA efficacy supplement submissions within
supplements in 10
10 months of receipt for 90% of submissions. FDA will review and act on months.
priority BLA efficacy supplement submissions within 6 months of receipt
90% of BLA
for 90% of submissions. FDA will review and act on Class 1 original BLA
resubmissions and BLA
and BLA efficacy supplement resubmissions within 2 months of receipt
supplement
for 90% of submissions. FDA will review and act on Class 2 original BLA
resubmissions in two
and BLA efficacy supplement resubmissions within 6 months of receipt
months
for 90% of submissions. FDA will review and act on BLA manufacturing
supplements requiring prior approval within 4 months of receipt for 90%
of submissions.
III. Shared
Process improvements in the agreement are intended to reduce the
New section.
Outcome Goal
average Total Time to Decision for PMAs and 510(k)s. FDA and
applicants share the responsibility for achieving this goal.
PMA. For submissions received beginning in FY2013, the average Total
Time to Decision goal for FDA and industry is 395 calendar days;
beginning in FY2015, 390 calendar days; beginning in FY2017, 385
calendar days.
510(k). For submissions received beginning in FY2013, the average Total
Time to Decision goal for FDA and industry is 135 calendar days;
beginning in FY 2015, 130 calendar days; beginning in FY 2017, 124
calendar days.
IV. Infrastructure
Scientific and Regulatory Review Capacity. User fees will be used to
New section.
reduce the ratio of review staff to supervisors and to enhance and
supplement scientific review capacity by hiring reviewers and leveraging
external experts needed to assist with device application review. FDA
will seek to obtain streamlined hiring authority and work with industry
to benchmark best practices for retaining employees (both financial and
non-financial).
Training. FDA wil hold at least two medical device Vendor Days each
FDA will apply user
year. User fees will supplement the fol owing: management training;
fees to support
MDUFA III train for all staff; Reviewer Certification Program for new
reviewer training that is
reviewers; specialized training to provide continuous learning for al staff.
related to the process
for the review of
devices, including
training to enhance
scientific expertise.
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Similar language in
MDUFA II
Topic
Draft MDUFA III commitments
commitments
Tracking System. IT system will be improved to allow real-time status
New section.
information for submissions.
V. Independent
By the end of the 2nd quarter of FY2013, FDA will award a contract to
New section.
Assessment of
assess the device application review process. Within 6 months of award,
Review Process
a report on recommendations likely to have a significant impact on
Management
review time will be published; final report will be published within 1 year
of contract award. FDA will publish an implementation plan within 6
months of receipt of each report. The contractor will evaluate FDA’s
implementation and publish a report no later than February 1, 2016.
VI. Performance
Information to be covered in quarterly reports by CDRH and CBER is
FDA reports quarterly
Reports
listed for: 510(k)s, PMAs; Pre-Submissions; and, IDEs. CDRH reports
on progress toward
quarterly and CBER reports annual y on eleven data points such as: NSE
attaining quantitative
decisions for 510(k)s; withdrawls of 510(k)s and PMAs; not approvable
goals. For all
decisions for PMAs; other noteworthy issues like rates of AI letters;
submission types, FDA
number of submissions that missed goals; new draft and final guidance;
will track total time
fee col ection summary; independent assessment implementation plan
from receipt to final
status; number of discretionary fee waivers. FDA reports annually on
decision. FDA provides
nine topics such as: use of fees for enhanced scientific review capacity;
annual y review
number of Premarket Report Submissions; summary of training courses;
performance data by
shared outcome goal performance; 510(k) submissions; PMA
branch (grouped by
submissions; DeNovo classification petitions; CLIA waiver applications.
subject), indicating the
shortest and longest
average review times
for 510(k)s, 180-day
supplements, and real-
time supplements.
VII. Discretionary
FDA wil seek authority to grant discretionary fee waivers or reduced
New section.
Waiver
fees in the interest of public health. Authority for the waiver and reduced
fees expires at the end of MDUFA III.
VIII. Definitions and
Total Time to Decision is the number of calendar days from the date to
The following terms
explanations of
receipt or filed submission to a MDUFA decision.
were defined: FDA
terms
Decision; Expedited
The average Total Time to Decision for 510(k) submissions is calculated
Review; PMA Modules;
as the trimmed mean of Total Times to Decision for 510(k) submissions
180-Day PMA
within a closed cohort, excluding the highest 2% and the lowest 2% of
Supplements; and, Real-
values. A cohort is closed when 99% of the accepted submissions have
Time Supplements.
reached a decision. A cohort consists of al submissions of a certain type,
in this case 510(k), filed in the same fiscal year.
The average Total Time to Decision for PMA applications is calculated as
the three-year rolling average of the annual Total Times to Decision for
applications (for example, for FY2015, the average Total Time to
Decision for PMA applications would be the average of FY2013 through
FY2015) within a closed cohort, excluding the highest 5% and the lowest
5% of values. A cohort is closed when 95% of the applications have
reached a decision. A cohort consists of al submissions of a certain type,
in this case PMA, filed in the same fiscal year.
Other terms that are defined: Applicant; Electronic Copy; FDA Days;
MDUFA decisions; Pre-Submission; and, Substantive Interaction. Three
BLA-related definitions are also provided: Review and act on; Class 1
resubmitted applications; and, Class 2 resubmitted applications.
Source: FDA, “Draft MDUFA III Commitment Letter,” dated February 17, 2012, and posted on FDA website
March 14, 2012, at http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/
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UCM295454.pdf. Document is referred to, at times, as the Commitment Letter or the Agreement; and FDA,
“MDUFA 2007 Commitment Letter,” dated September 27, 2007, and posted on FDA website at
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/
MedicalDeviceUserFeeandModernizationActMDUFMA/default.htm.
Note: Topic numbering corresponds to the ordering in draft MDUFA III Agreement; these are usual y different
from the MDUFA II (2007) numbering.
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Appendix C. MDUFMA and MDUFA: Fees and
Performance Goals

Table C-1. MDUFMA/MDUFA 2007 Fee Schedule, FY2007-FY2012
MDUFMA
MDUFA 2007
Fees Structure
2007
2008
2009
2010
2011
2012
Application Fees
PMA (i.e., base fee)

$281,600 $185,000 $200,725 $217,787 $236,298 $256,384
Small
Businessa
$107,008 $46,250 $50,181 $54,447 $59,075 $64,096
Panel Track Supplementb

$281,600 $138,750 $150,544 $163,340 $177,224 $192,288
Small
Businessa
$107,008 $34,688 $37,636 $40,835 $44,306 $48,072
180-Day Supplementc

$60,544 $27,750 $30,109 $32,668 $35,445 $38,458
Small
Businessa
$23,007 $6,938 $7,527 $8,167 $8,861 $9,614
Real Time Supplementd

$20,275 $12,950 $14,051 $15,245 $16,541 $17,947
Small
Businessa
$7,705 $3,237 $3,512 $3,810 $4,134 $4,485
510(k)

$4,158 $3,404 $3,693 $4,007 $4,348 $4,717
Small
Businessa
$3,326 $1,702 $1,847 $2,004 $2,174 $2,359
30-Day Noticee

$2,960 $3,212 $3,485 $3,781 $4,102
Small
Businessa
$1,480 $1,606 $1,742 $1,890 $2,051
513(g)f

$2,498 $2,710 $2,940 $3,190 $3,461
Small
Businessa
$1,249 $1,355 $1,470 $1,595 $1,731
Product Fee
Annual Fee for Periodic Report.

$6,475
$7,025
$7,623
$8,270
$8,973
Small
Businessa

$1,619 $1,756 $1,906 $2,068 $2,243
Establishment Fee
Establishment
Registration


$1,706 $1,851 $2,008 $2,179 $2,364
Source: FDA, Medical Devices: Proposed Industry User Fee Schedule for MDUFMA II, March 3, 2009, accessed on
January 31, 2012, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/
MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109319.htm.
a. Small Business—indicates the reduced small business fee associated with the item listed above.
b. Panel-Track Supplement—manufacturer requests approval of a significant change in the design or
performance of a device approved via the PMA pathway; significant amount of clinical data evaluated.
c. 180-Day PMA Supplement—manufacturer requests approval of a change in aspects of an approved device,
such as its design, specifications, or labeling; new clinical data not required or only limited clinical data.
d. Real-Time PMA Supplement—manufacturer requests approval for a minor change to an approved device,
such as a minor change in the design or labeling.
e. 30-Day Notice—manufacturer requests permission to make modifications to manufacturing procedures or
methods of manufacture affecting the safety and effectiveness of the device.
f.
513(g)—manufacturer requests information on the classification of a device.
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Appendix D. MDUFA III Performance Goals
Table D-1. Summary of Performance Goals per February 7, 2012, Agreement
2008-
2013-2017 (01/31/2012 Agreement) - all in FDA
2007
2012
Days except Average Total
End of
MDUFMA MDUFA
Submission Type
I
II FY13 FY14 FY15 FY16 FY17
Tier I
80% in 90
90% in
91% in
93% in
95% in
95% in
95% in
days
90 days
90 days
90 days
90 days
90 days
90 days
Tier 2
N.A.
98% in





150 days
Cycle
90% in 75
N.A. N.A. N.A. N.A. N.A. N.A.
510(k)
days
Interaction N.A. N.A.
65% in
75% in
85% in
95% in
95% in
60 days
60 days
60 days
60 days
60 days
Average
Total

N.A.
N.A.
135 days 135 days 130 days 130 days 124 days
Time
Tier 1

90% in 180
85% in
85% in
90% in
90% in
95% in
95% in
days
180 days
180 days 180 days 180 days 180 days 180 days
Tier 2
N.A.
95% in





180 Day
210 days
PMA
Cycle
90% in 120
N.A. N.A. N.A. N.A. N.A. N.A.
Supplement
days
Interaction N.A. N.A.
65% in
75% in
85% in
95% in
95% in
90 days
90 days
90 days
90 days
90 days

Tier 1 -
Tier 1 -
No
No
No
No
No
50% in 180
60% in
Panel -
Panel -
Panel -
Panel -
Panel -
days
180 days
70% in
80% in
80% in
90% in
90% in
180 days 180 days 180 days 180 days 180 days
Tier 2 -
Tier 2 -
With
With
With
With
With
90% in 320
90% in
Panel -
Panel -
Panel -
Panel -
Panel -
Original
days
295 days
50% in
70% in
80% in
80% in
90% in
PMAs &
320 days 320 days 320 days 320 days 320 days
Panel Track
Cycle
75% in 150
N.A. N.A. N.A. N.A. N.A. N.A.
Supplements
days
Interaction N.A. N.A.
65% in
75% in
85% in
95% in
95% in
90 days
90 days
90 days
90 days
90 days
Average
Total

N.A.
N.A.
395 days 395 days 390 days 390 days 385 days
Time
Tier 1

90% in 300
50% in
Included
Included
Included
Included
Included
days
180 days
with
with
with
with
with
Expedited
Tier 2
N.A.
90% in
“Original "Original "Original "Original "Original
PMAs
280 days
PMAs"
PMAs"
PMAs"
PMAs"
PMAs"
Cycle
70% in 120
N.A.
90% in
90% in
95% in
95% in
95% in
days
90 days
90 days
90 days
90 days
90 days
Tier 1
N.A.
80% in
90% in
95% in
95% in
95% in
90% in
Real Time
60 days
210 days 180 days 180 days 180 days 90 days
PMA
Supplements
Tier 2
N.A.
90% in
90% in
95% in
95% in
95% in
95% in
90 days
180 days 330 days 330 days 330 days 330 days
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The FDA Medical Device User Fee Program

2008-
2013-2017 (01/31/2012 Agreement) - all in FDA
2007
2012
Days except Average Total
End of
MDUFMA MDUFA
Submission Type
I
II FY13 FY14 FY15 FY16 FY17
Dual
N.A. N.A.
90% in
90% in
90% in
90% in
90% in
CLIA/
210 days 210 days 210 days 210 days 210 days
510(k)
CLIA
Waiver

CLIA –
N.A. N.A.
95% in
95% in
95% in
95% in
95% in
Applications
no panel
180 days 180 days 180 days 180 days 180 days
CLIA –
N.A. N.A.
95% in
95% in
95% in
95% in
95% in
with panel
330 days 330 days 330 days 330 days 330 days
Source: FDA, MDUFA Reauthorization Public Meeting, Slide 17, March 28, 2012.
Note: N.A. = Not Applicable.
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The FDA Medical Device User Fee Program

Appendix E. Acronyms Used in This Report
510(k) Premarket
Notification
513(g)
Request for Information About Device Classification
BLA
Biologics License Application
CBER
Center for Biologics Evaluation and Research
CDRH
Center for Devices and Radiological Health
CLIA
Clinical Laboratory Improvement Amendments
FDA
United States Food and Drug Administration
FFDCA
Federal Food, Drug, and Cosmetic Act (21 U.S.C. Chapter 9)
FTE
Ful Time Equivalent Employee
GAO Government
Accountability Office (formerly General Accounting Office)
HDE
Humanitarian Device Exemption
HELP
Senate Health, Education, Labor and Pensions Committee
HHS
United States Department of Health and Human Services
IDE
Investigational Device Exemption
MDTCA
Medical Device Technical Corrections Act
MDUFMA
Medical Device User Fee and Modernization Act
MDUFA II
Medical Device User Fee Amendments of 2007
MDUFSA
Medical Device User Fee Stabilization Act of 2005
MQSA
Mammography Quality Standards Act
NSE Non-Substantial
Equivalence
PDP
Product Development Protocol
PDUFA
Prescription Drug User Fee Act
PL Public
Law
PMA Premarket
Approval
RIF
Reduction in Force
SE Substantial
Equivalence
SUD Single-Use
Device
USC
United States Code


Author Contact Information

Judith A. Johnson

Specialist in Biomedical Policy
jajohnson@crs.loc.gov, 7-7077

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