Medical Device User Fee and Modernization Act (MDUFMA) Reauthorization

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Medical Device User Fee and Modernization

Act (MDUFMA) Reauthorization

(name redacted)

Specialist in Public Health and Bioethics

July 12, 2007

Congressional Research Service

7-....

www.crs.gov

RL33981

CRS Report for Congress

Prepared for Members and Committees of Congress

Medical Device User Fee and Modernization Act (MDUFMA) Reauthorization

Summary

Unless Congress acts to reauthorize it, the Food and Drug Administration’s (FDA’s) authority to

collect user fees under the Medical Device User Fee and Modernization Act (MDUFMA; P.L.

107-250) and, by reference, FDA’s obligation to meet related performance goals, will expire on

October 1, 2007. According to the President’s budget request, in FY2008, funds from a

reauthorized MDUFMA would account for an estimated $47.5 million and 200 full-time

equivalent employees (FTEs). This would comprise 16.6% of FDA’s medical device review

budget authority and 13.0% of its medical device review-related FTEs. While these numbers and

percentages are not as high as those projected for collection under a similar FDA user fee

authority related to prescription drugs (pursuant to the Prescription Drug User Fee Act), they are

significant.

For MDUFMA as passed in 2002, the fee amounts and performance goals articulated and

incorporated in statute were the result of an agreement between FDA and the medical device

industry. In order to facilitate the reauthorization of MDUFMA, in April 2007, the FDA and

industry published the results of their negotiations with a notice of an April 30, 2007, public

meeting on the topic. According to FDA, during the five years covered by the proposals (through

2012), FDA would receive approximately $287 million from user fees. This represents an

increase from the $110 million FDA received during the first four years of the program.

The industry agreement also calls for changes in the fee structure, performance goals, small

business relief, and third-party inspection program. In addition, the agreement reflects FDA’s

initiatives related to the regulation of in vitro diagnostic devices (laboratory tests). (MDUFMA

enabled third-party inspections and set standards for the use of reprocessed single-use devices.)

The details of the proposed reauthorization of MDUFMA have been incorporated, with a few

exceptions, into the Medical Device User Fee Amendments of 2007 (MDUFA 2007). On May 9,

2007, MDUFA 2007 passed the Senate as Title III of the Food and Drug Administration

Revitalization Act (S. 1082). On July 11, 2007, the House passed it as Title II of the Food and

Drug Administration Amendments Act of 2007 (H.R. 2900). The bills’ MDUFA 2007 provisions

are similar, but not identical. Differences between them are expected to be addressed in

conference. The provisions of MDUFMA and the proposals for MDUFA 2007 are discussed in

this report, following an introduction to FDA’s medical device review process.

This report will be updated as event warrant.

Congressional Research Service

Medical Device User Fee and Modernization Act (MDUFMA) Reauthorization

Contents

Overview: FDA and Medical Device Review ..............................................................................1

MDUFMA and MDUFA 2007.....................................................................................................4

User Fees ..............................................................................................................................5

Triggers ..........................................................................................................................5

User Fees, Device Review Budget and FTEs...................................................................6

Activities Requiring Fees, and Exceptions to the General Rule ........................................7

Use of Fees ................................................................................................................... 11

Performance Goals........................................................................................................ 12

Accredited Third-Party Inspections ..................................................................................... 14

Reprocessed Single-Use Devices......................................................................................... 15

Other MDUFA 2007 Provisions........................................................................................... 16

Annual Reports ............................................................................................................. 16

Postmarket Safety Appropriations Authorization ........................................................... 16

Nosocomial Infections .................................................................................................. 18

Other MDUFMA Provisions ............................................................................................... 18

FDA Agreement Recommendations not in MDUFA 2007 .................................................... 18

Interactive Review ........................................................................................................ 18

Guidance Document Development ................................................................................ 19

Diagnostic Imaging Products......................................................................................... 19

In Vitro Diagnostics (IVDs) .......................................................................................... 19

Meetings ....................................................................................................................... 20

Tables

Table 1. Medical Device Approval Basics....................................................................................2

Table 2. Premarket Approvals (PMAs), Panel-Track Supplements,

and Premarket Notification (510(k)s), FY2003-FY2006 ...........................................................3

Table 3. Statutory Triggers for MDUFMA (FDA’s Salaries and Expense Appropriation

Line for Devices and Radiological Health, Exclusive of User Fees) ..........................................6

Table 4. Funding for the Device Review Process Salaries and Expenses, FY2003-FY2008 ..........6

Table 5. Full Time Employees (FTEs) in the Device Review Process, FY2003-FY2008...............7

Table 6. Proposed MDUFA 2007 User Fee Revenue (S. 1082, H.R. 2900, and FDA

Agreement) and Total Dollars Needed for the Device Review Process, FY2008-FY2012..........7

Table 7. MDUFMA Fee Schedule, Current FY2007, Proposed FY2008-FY2012 .........................8

Table 8. MDUFMA Base Fee Rates, FY2003-FY2007 ................................................................9

Table 9. Use of MDUFMA Fees ................................................................................................ 12

Table 10. Comparison of Quantitative Decision Performance Goals in

MDUFMA and MDUFA 2007................................................................................................ 13

Table 11. CDRH Warning Letters Issued in Total and Under the MQSA, FY2000-FY2007 ........ 17

Congressional Research Service

Medical Device User Fee and Modernization Act (MDUFMA) Reauthorization

Appendixes

Appendix. Acronyms Used in This Report................................................................................. 21

Contacts

Author Contact Information ...................................................................................................... 21

Congressional Research Service

Medical Device User Fee and Modernization Act (MDUFMA) Reauthorization

Overview: FDA and Medical Device Review

In order to understand the significance of MDUFMA, a basic introduction to FDA and the

medical device review process is useful. The United States Food and Drug Administration (FDA)

is the agency responsible for ensuring the safety and effectiveness of medical devices in the

United States. According to statute, a medical device is

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. (Federal Food, Drug and Cosmetic Act, 21

U.S.C. 301 §201(h)) (FFDCA).

According to this definition, a medical device can be anything from a tongue depressor to a

home pregnancy test to a wheelchair to a pacemaker. Types of medical devices vary widely, as

do their respective manufacturing requirements. In part due to the diversity of medical devices,

compared to the drug industry, the device industry is more fragmented, smaller (estimated

earnings of $80 billion in 2004 compared to the drug industry’s estimated $222 billion), and

dominated by smaller companies.

FDA is divided into six centers, each charged with regulating a particular type of product. The

center within FDA primarily responsible for ensuring the safety and effectiveness of medical

devices is the Center for Devices and Radiological Health (CDRH). One other center, the Center

for Biologics Evaluation and Research (CBER), regulates some devices—specifically those

associated with blood collection and processing procedures, as well as with cellular therapies

(e.g., stem cell treatments). Jurisdiction of the centers’ medical device review is governed by the

FDA Intercenter Agreement between CBER and CDRH (October 31, 1991).1

CDRH categorizes medical devices according to their risk into one of three classes: Class I, II,

and III. (See Table 1.) The risk a device poses, and the regulatory controls required, increase from

Class I to Class III. The device classification regulation defines the regulatory requirements for a

general device type. Most Class I devices are exempt from Premarket Notification (510(k)) and

require only registration with FDA before marketing; most Class II devices require a 510(k)

before marketing; and most Class III devices require Premarket Approval (PMA). Most PMAs

and some 510(k)s require clinical trials,2 which are conducted with FDA permission via an

investigational device exemption (IDE) that allows a device to be used in a study to gather

information on its safety and effectiveness. Devices are reviewed by CBER under a biological

license application (BLA).

FDA, “Devices Regulated by CBER,” (updated March 15, 2007), at http://www.fda.gov/cber/dap/devlst.htm.

For more information on the regulation and sharing of results from clinical trials, see CRS Report RL32832, Clinical

Trials Reporting and Publication, by (name redacted), and CRS Report RL32909, Federal Protection for Human

Research Subjects: An Analysis of the Common Rule and Its Interactions with FDA Regulations and the HIPAA

Privacy Rule, by (name redacted).

Congressional Research Service

Medical Device User Fee and Modernization Act (MDUFMA) Reauthorization

Table 1. Medical Device Approval Basics

Device

Classification

Examples

Safety/Effectiveness

Controls

Required Submission

Class I

elastic bandages,

examination gloves, and

hand-held surgical

instruments

General Controlsa

-Registration only unless 510(k)

specifically required

Class II

powered wheelchairs,

infusion pumps, and surgical

drapes

General Controls &

Special Controlsb

-510(k) clearance unless exempt

-IDE possible

Class III

heart valves, silicone gelfilled breast implants, and

implanted cerebella

stimulators

General Controls &

Premarket Approval

-PMA approval unless 510(k)

specifically permitted

-IDE probable

General controls include five elements: establishment registration (use FDA Form 2891) of companies

which are required to register under 21 CFR part 807.20, such as manufacturers, distributors, repackagers

and relabelers, and foreign firms; medical device listing (use FDA Form 2892) with FDA of devices to be

marketed; manufacturing devices in accordance with the Quality Systems regulation (GMPs) in 21 CFR Part

820; labeling devices in accordance with labeling regulations in 21 CFR Part 801 or 809; and submission of a

premarket notification 510(k) before marketing a device. (Most Class I devices are exempt from the

premarket notification and/or the Quality System Regulation).

Special controls may include special labeling requirements, mandatory and voluntary performance standards

and postmarket surveillance.

To supplement a PMA when there are changes in safety and effectiveness data, FDA may require

one of four types of submissions: Panel Track Supplements, 180-Day Supplements, Real Time

Supplements, and 30-Day Notices. Panel Track Supplements are akin to second entire PMAs.

They reflect new indications for use or significant changes in device design or performance, and

require substantial clinical data. As artificial heart valve approved for use to replace the aortic

valve, and proposed for use in the mitral valve, would require the submission of a Panel Track

Supplement. 180-Day Supplements are submitted for significant changes to medical device

components, materials, designs, specifications, software, labeling, or color additives. A proposed

change in a blood glucose monitoring system from wired to wireless telemetry would require this

type of submission. Real Time Supplements are submitted when there are minor changes to the

design, software, sterilization or labeling of a device. A change in the storage temperature and

expiration dating for an injectable gel would require this type of supplement. 30-Day Notices are

submitted for modifications to manufacturing processes or methods, such as a change in the

sterilization process.

FDA offers one alternative that can be used in place of a PMA: the Product Development

Protocol (PDP). A PDP is based upon early consultation between the sponsor and the FDA,

leading to a device development and testing plan acceptable to both parties. It aims to minimize

the risk that the sponsor will unknowingly pursue—with the associated waste of capital and other

resources—the development of a device that FDA will not approve.

One additional type of submission is a 513(g) request, so named because of the section of the

FFDCA that regulates it. 513(g)s enable requesters to obtain information from FDA regarding the

regulatory status of their devices or products.

Congressional Research Service

Medical Device User Fee and Modernization Act (MDUFMA) Reauthorization

Of all device-related submissions, a PMA (or Panel Track Supplement) is the most rigorous and

time consuming application process for manufacturers and review process for the FDA. A 510(k)

is significantly less rigorous, and is much more common. The majority of medical devices that

come to market do so with 510(k) clearance rather than PMA approval. (See Table 2.)

Table 2. Premarket Approvals (PMAs), Panel-Track Supplements,

and Premarket Notification (510(k)s), FY2003-FY2006

PMAs and

Panel-Track

Supplements

510(k)sa

FY2003

3,795

FY2004

3,383

FY2005

3,415

FY2006

3,732

Source: MDUFMA quarterly report, at http://www.fda.gov/cdrh/mdufma/reports%5Cquarterlysummary.pdf.

The chart excludes 510(k)s that were closed for any reason other than an FDA determination of substantial

equivalence (SE, which results in FDA clearance) or a finding of non-substantial equivalence (NSE, which does

not result in FDA clearance), for example, when FDA finds that a 510(k) was not required. The number of

510(k)s in the MDUFMA Cohort is subject to change until the cohort is complete.

In the years prior to MDUFMA’s enactment, FDA’s resources for its device and radiological

health programs had increased at a lower rate than its costs.3 As stated in the House Report to

H.R. 3580 (MDUFMA):

The medical device industry is growing rapidly. The complexity of medical device

technology is increasing at an equally rapid pace. Unfortunately, FDA’s device review

program lacks the resources to keep up with the rapidly growing industry and changing

technology. Because prompt approval and clearance of safe and effective medical devices is

critical to improving public health, it is the sense of the Committee that adequate funding for

the program is essential.4

In addition to filing applications for clearance or approval with FDA, device manufacturers must

be registered with FDA and file annual reports. In addition, FDA inspects establishments where

medical devices that are marketed in the United States are manufactured to assess compliance

with FDA’s quality system requirements for ensuring good manufacturing practices (GMP) and

other applicable requirements. According to the Government Accountability Office (GAO):

During quality system inspections, FDA investigators examine manufacturing

controls, processes, and records. These inspections are FDA’s primary means of assuring

that the safety and effectiveness of medical devices are not jeopardized by poor

manufacturing practices.5

FDA, “Medical Device User Fee and Modernization Act; Public Meeting,” Federal Register, vol. 72, no. 74, p.

19528, (April 18, 2007) at http://frwebgate5.access.gpo.gov/cgi-bin/

waisgate.cgi?WAISdocID=268837241492+0+0+0&WAISaction=retrieve.

U.S. Congress, “House Committee on Energy and Commerce, Medical Device User Fee and Modernization Act of

2002,” report to accompany H.R. 3580,107th Cong., 2nd sess., part 1 (Washington: GPO, 2002), pp. 23.)

Government Accountability Office, “Medical Devices: Status of FDA’s Program for Inspections by Accredited

(continued...)

Congressional Research Service

Medical Device User Fee and Modernization Act (MDUFMA) Reauthorization

In addition to issues raised by medical device review funding and inspection capabilities at FDA,

prior to MDUFMA, concerns had also emerged regarding the reprocessing and re-use of medical

devices that FDA had cleared or approved as single use devices (SUDs). Reprocessing means

cleaning and sterilizing a device and verifying that it functions properly. Concerns about SUDs as

well as funding and inspections paved the way for Congressional action in 2002 as described in

the next section.

MDUFMA and MDUFA 2007

Prior to the enactment of Medical Device User fee and Modernization Act ( P.L. 107-250,

hereinafter referred to as MDUFMA), FDA officials met with industry leaders, to agree upon

mutually acceptable fee types, amounts, exceptions, and performance goals. 6 The agreement

specified that, in return for the additional resources provided by medical device user fees, FDA

was expected to meet performance goals defined in a November 14, 2002 letter from the

Secretary of the Department of Health and Human Services (HHS) to the Chairman and Ranking

Minority Members of the Committee on Health, Education, Labor and Pensions Committee of the

U.S. Senate and the Committee on Energy and Commerce of the U.S. House of Representative.7

MDUFMA was enacted in order to provide FDA “with the resources necessary to better review

medical devices, to enact needed regulatory reforms so that medical device manufacturers can

bring their safe and effective devices to the American people at an earlier time, and to ensure that

reprocessed medical devices are as safe and effective as original devices.”8 MDUFMA amended

the FFDCA to enact three significant provisions for medical devices: (1) it established user fees

for premarket reviews of devices; (2) it allowed establishment inspections to be conducted by

accredited persons (third parties); and (3) it instituted new regulatory requirements for

reprocessed single-use devices. FDA’s authority for the first of these (the collection of user fees)

will expire on October 1, 2007, unless Congress reauthorizes it.

MDUFMA was subsequently amended by two laws: the Medical Device Technical Corrections

Act (MDTCA, P.L. 108-214), and the Medical Device User Fee Stabilization Act of 2005

(MDUFSA, P.L. 109-43). Unless otherwise noted, the discussion of MDUFMA that follows

incorporates the amendments made by MDTCA and MDUFSA.

In preparation for reauthorization (MDUFA 2007), FDA and industry representatives announced

in April 2007 that they had reached a proposed mutual agreement on terms (“FDA Agreement”).

Pursuant to MDUFMA (§105), on April 30, 2007, FDA held a public meeting about the FDA

Agreement. Attendees expressed general satisfaction with its terms.

(...continued)

Organizations,” Report to Congress GAO-07-157 (January 2007).

This process was similar to the one used previously during the enactment and reauthorization of the user fee act for

prescription drugs, the Prescription Drug User Fee Act (PDUFA). For further information on PDUFA, see CRS Report

RL33914, The Prescription Drug User Fee Act (PDUFA): History, Reauthorization in 2007, and Effect on FDA, by

(name redacted).

This letter is generally referred to as the “FDA Commitment Letter.” See 148 Cong. Rec. S11549-01(2002).

Medical Device User Fee and Modernization Act of 2002, H.Rept. 107-728 (October 7, 2002), p. 21.

Congressional Research Service

Medical Device User Fee and Modernization Act (MDUFMA) Reauthorization

The terms of the FDA Agreement were, by and large, incorporated into the Food and Drug

Administration Revitalization Act (S. 1082), which the Senate passed on May 9, 2007. They have

also been generally incorporated into the Food and Drug Administration Amendments Act of

2007 (H.R. 2900), which the House passed on July 11, 2007. The two bills’ MDUFA 2007

provisions are similar, but not identical, as explained below. Differences are expected to be

addressed in conference. Like MDUFMA, MDUFA 2007 proposals address both user fee

authorities and third-party inspection. The proposed MDUFA 2007 user fee provisions would

sunset on October 1, 2012. These as well as other MDUFMA provisions and other related topics,

such as the impact that MDUFMA has had on postmarket inspection and enforcement, are

discussed in the remainder of this report.

User Fees

Several important aspects of MDUFMA and MDUFA 2007 are related to user fees, including

statutory “triggers” that link FDA’s authority to collect and spend user fees to levels of

Congressional appropriations, as well as reductions and exemptions to fees, performance goals,

and allowable uses of fees.

Triggers

The authority to collect MDUFMA user fees is subject to statutory triggers that prohibit the

collection of the fees if direct Congressional appropriations to FDA for salaries and expenses

related to devices and radiological health fall below a certain threshold. In 2005, legislation was

required to enable the continuation of the MDUFMA user fee program because Congressional

appropriations had been lower than required for FY2003 and FY2004. MDUFSA (the 2005

legislation) lowered the MDUFMA triggers retroactively for FY2003 and FY2004 and

prospectively for FY2005-FY2007.

According to MDUFSA, FDA’s salaries and expense appropriation line for Devices and

Radiological Health, exclusive of user fees, must be not more than 1% below $205,720,000,

plus statutory adjustments for FY2005-FY2007.9 For FY2007, this translates into a minimum

requirement of $229,334,000. (See Table 3.) No statutory trigger has been set for years

beyond FY2007. MDUFA 2007 proposes that the MDUFSA trigger language be maintained

through FY2012.

FDA Office of Management, “Funding For MDUFMA and ADUFA Triggers,” FY2007 Budget Formulation and

Presentation, (February 22, 2006), at http://www.fda.gov/oc/oms/ofm/budget/2007/HTML/

7UserFeeTriggersBCPPOM.htm.

Congressional Research Service

Medical Device User Fee and Modernization Act (MDUFMA) Reauthorization

Table 3. Statutory Triggers for MDUFMA (FDA’s Salaries and Expense Appropriation

Line for Devices and Radiological Health, Exclusive of User Fees)

Appropriated Levels

FY2005 Actual

$214,966,000

FY2006 Minimum Requirement

$222,654,000

FY2007 Minimum Requirement

$229,334,000

Source: FDA Office of Management, “Funding For MDUFMA and ADUFA Triggers,” FY2007 Budget

Formulation and Presentation, (Feb. 22, 2006), at http://www.fda.gov/oc/oms/ofm/budget/2007/HTML/

7UserFeeTriggersBCPPOM.htm.

User Fees, Device Review Budget and FTEs

The amount of FDA’s device review budget derived from MDUFMA user fees (private money)

has increased almost every year since the act became law. Over the period of FY2003 to FY2008,

MDUFMA funding has increased at a much faster rate (220.1%) than direct appropriations from

Congress (24.1%).10 MDUFMA fees comprised less than 7% of FDA’s program level device

review budget in FY2003, and estimates are that they will comprise over 16% in FY2008. (See

Table 4.) According to the President’s FY2008 budget request, MDUFMA fees would translate

into 200 FTEs for that year, or 13% of the FTEs in the device review process (See Table 5).

Table 4. Funding for the Device Review Process Salaries

and Expenses, FY2003-FY2008

(dollars in thousands)

Total Program

Level

MDUFMA User

Fees

MDUFMA/

Total

FY2003 Actual

$217,285

$14,838

6.8%

FY2004 Actual

$179,245

$23,875

13.3%

FY2005 Actual

$244,282

$27,161

11.1%

FY2006 Actual

$255,041

$32,069

12.6%

FY2007 Pres. Budget

$271,571

$43,726

16.1%

FY2008 Pres. Budget

$285,376

$47,500

16.6%

Source: Food and Drug Administration tables for FY2005 - FY2008, “ALL PURPOSE TABLE - Total Program

Level,” at http://www.fda.gov/oc/oms/ofm/budget/documentation.htm.

Calculation is based upon FY2003 Actuals (MDUFMA: $14,838,000, FDA budget authority: $193,350,000), and the

FY2008 President’s Budget Request (MDUFMA: $47,500,000, FDA budget authority: $240,122,000).

Congressional Research Service

Medical Device User Fee and Modernization Act (MDUFMA) Reauthorization

Table 5. Full Time Employees (FTEs) in the Device Review Process, FY2003-FY2008

Total Device

Review FTEs

MDUFMAFunded FTEs

MDUFMAFunded / Total

FY2003 Actual

1,485

2.2%

FY2004 Actual

1,061

137

12.9%

FY2005 Actual

1,516

153

10.1%

FY2006 Actual

1,498

184

12.2%

FY2007 Pres. Budget

1,534

196

12.8%

FY2008 Pres. Budget

1,539

200

13.0%

Source: Food and Drug Administration tables for FY2005 - FY2008, “ALL PURPOSE TABLE - Total Program

Level,” at http://www.fda.gov/oc/oms/ofm/budget/documentation.htm.

MDUFA 2007 would increase the amount of fees and resulting FTEs each year until FY2012.

Total fee revenues in FY2008 would increase by approximately 31% over estimated FY2007 fee

revenues, and by 8.5% per year each subsequent year through FY2012, generating a total of $287

million over five years. (See Table 6.)

Table 6. Proposed MDUFA 2007 User Fee Revenue (S. 1082, H.R. 2900, and FDA

Agreement) and Total Dollars Needed for the Device Review Process, FY2008FY2012

Total Device

Review Program

Requirement

MDUFMA User

Fee Authorised

Approps

MDUFMA/

Total

FY2008

$220,000

$ 48,431

22.0%

FY2009

$ 234,000

$ 52,547

22.5%

FY2010

$ 249,000

$ 57,014

22.9%

FY2011

$ 265,000

$ 61,860

23.3%

FY2012

$ 281,000

$ 67,118

23.9%

Source: FDA, “Medical Device User Fee and Modernization Act; Public Meeting,” Federal Register, vol. 72,

no. 74, p. 19528, (April 18, 2007) at http://frwebgate5.access.gpo.gov/cgi-bin/

waisgate.cgi?WAISdocID=268837241492+0+0+0&WAISaction=retrieve.

Activities Requiring Fees, and Exceptions to the General Rule

MDUFMA gives FDA the authority to collect user fees from manufacturers seeking to market

medical devices. All of the fees charged under MDUFMA are for types of applications

required for FDA approval or clearance of a product. According to FDA, there were fluctuations

in the number of applications submitted from year to year, and fee revenues repeatedly fell short

of expectations.11

FDA, “Medical Device User Fee and Modernization Act; Public Meeting,” Federal Register, vol. 72, no. 74, p.

19528, (April 18, 2007) at http://frwebgate5.access.gpo.gov/cgi-bin/

waisgate.cgi?WAISdocID=268837241492+0+0+0&WAISaction=retrieve.

Congressional Research Service

Medical Device User Fee and Modernization Act (MDUFMA) Reauthorization

To remedy the situation, MDUFA 2007 would introduce three new types of fees, which would

generate about 50% of the total fee revenue and that would be more stable than application fees.

The new fees are an annual establishment registration fee (paid once each year by each

manufacturer), an annual fee for filing periodic reports (applicable to Class III devices approved

under PMAs, premarket reports, and PDP processes), and a fee for filing a 30-Day Notice. The

FDA Agreement states that the implementation of these new fees would allow for significant

reduction in MDUFA 2007 of existing application fees. (See Table 7.) Generally, fees would

increase each year by 8.5%, which, according to FDA’s recommendation, would ensure that fee

revenues contribute their expected share to total program costs, and provide industry with

stability and predictability in the fee revenues it would expect to pay. For the newly created

establishment fee, the Secretary could increase the fee amount in FY2010 up to an additional

8.5% over the annual 8.5% increase if fewer than 12,250 establishments paid the fee in FY2009.

This measure is designed to ensure that the fees collected from this source total 45% of total

fee revenues.

Both MDUFMA and proposals for MDUFA 2007 set fees as a percentage of the full fee for a

PMA, also called the base fee, which is generally the most involved type of application that a

device manufacturer could make to FDA (FFDCA § 738(a)(2)(A)). 12 During the course of

MDUFMA, the amount of the base fee (and thus the amounts of all of the other fees) rose each

year, from $154,000 in FY2003 to $281,600 in FY2007 (FFDCA § 738(c)(1)). (See Table 8). The

percentages of the base fee assigned to various types of submissions have changed slightly from

MDUFMA to MDUFA 2007, but the concept is the same. The following is one example from

MDUFA 2007: a 30-day notice fee is equal to 1.6% of the base fee.

MDUFA 2007 would strike a provision that enables the Secretary to adjust the premarket

notification fee amount annually so that, in aggregate, these fees comprise a target amount.

However, H.R. 2900 would maintain a reference to this deleted provision in the Fee Amounts

section (21 U.S.C. 379j(a)(2)(A)).

Table 7. MDUFMA Fee Schedule, Current FY2007, Proposed FY2008-FY2012

Current

Fees Structure

Proposed MDUFA 2007

2007

2008

2009

2010

2011

2012

PMA/BLA

$281,600

$185,000

$200,725

$217,787

$236,298

$256,384

Sm. Bus.a

$107,008

$46,250

$50,181

$54,447

$59,075

$64,096

Panel Track Supplements

$281,600

$138,750

$150,544

$163,340

$177,224

$192,288

Sm. Bus.a

$107,008

$34,688

$37,636

$40,835

$44,306

$48,072

180-Day Supplements

$60,544

$27,750

$30,109

$32,668

$35,445

$38,458

Sm. Bus.a

$23,007

$6,938

$7,527

$8,167

$8,861

$9,614

Real Time Supplements

$20,275

$12,950

$14,051

$15,245

$16,541

$17,947

Sm. Bus.a

$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

Sm. Bus.a

$3,326

$1,702

$1,847

$2,004

$2,174

$2,359

For more information, see the PMA subsection of the Device Approval Process portion of this report.

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Current

Fees Structure

Proposed MDUFA 2007

2007

2008

2009

2010

2011

2012

30-Day Notice

$ 2,960

$ 3,212

$ 3,485

$ 3,781

$ 4,102

Sm. Bus.a

$ 1,480

$ 1,606

$ 1,742

$ 1,890

$ 2,051

513(g)

$ 2,498

$ 2,710

$ 2,940

$ 3,190

$ 3,461

Sm. Bus.a

$ 1,249

$ 1,355

$ 1,470

$ 1,595

$ 1,731

Establishmt. Registration

$ 1,706

$ 1,851

$ 2,008

$ 2,179

$ 2,364

Annual Report Filing

$ 6,475

$ 7,025

$ 7,623

$ 8,270

$ 8,973

Sm. Bus.a

$ 1,619

$ 1,756

$ 1,906

$ 2,068

$ 2,243

Source: FDA, “Proposed Industry User Fee Schedule for MDUFA 2007,” Center for Devices and Radiological

Health website, (Updated April 16, 2007), at http://www.fda.gov/cdrh/mdufma/mdufmaii-comparison.html.

Sm. Bus. indicates the reduced small business fee associated with whatever item is listed above. (For more

on the small business fee reduction, see the small business subsection below).

Table 8. MDUFMA Base Fee Rates, FY2003-FY2007

FY2003

FY2004

FY2005

FY2006

FY2007

$154,000

$206,811

$239,237

$259,600

$281,600

Source: “Fees” section, MDUFMA website of FDA’s Center for Biologics Evaluation and Research (updated

Aug. 2, 2006), at http://www.fda.gov/cber/mdufma/mdufma.htm.

Fee-Collection Offset

MDUFMA requires FDA to reduce fees in a subsequent year if collections in any year exceed the

amount authorized, but does not have a parallel provision to increase fees in a subsequent year if

collections fall short of amounts appropriated from fees. MDUFA 2007 would allow FDA to

aggregate all fees collected from FY2008 through FY2011 and compare that amount to the

aggregate amount authorized for the same period. A reduction would be made in fees in the final

year only if the amount collected in the four-year period exceeded the amount authorized for the

same period. According to the FDA Agreement, FDA believes this aggregation over four years

will provide for greater financial stability for FDA than treating each year in isolation.

Fee Exceptions, Reductions, Refunds

Certain types of devices, sponsors and activities qualify for exceptions to certain fees, small

businesses are charged a reduced rate.13 These fee reductions, exemptions, and refunds are

explained below. These are the same for MDUFMA and proposals for MDUFA 2007, except that

the latter would qualify only federal or state Government Entities for an exemption from the new

annual establishment registration fee, would expand and enhance the small business fee

reduction, and would allow a partial refund for withdrawal of a particular kind of PMA, as

explained below.

Federal Food Drug and Cosmetic Act, sec. 738(a)(2)(B).

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Humanitarian Use Devices (HUDs). HUD applications are exempt from MDUFMA fees. An

HUD is a device that is intended to treat or diagnose a disease or condition that affects fewer than

4,000 individuals in the United States per year. A device manufacturer’s research and

development costs could exceed its market returns for diseases or conditions affecting small

patient populations. FDA, therefore, developed and published this regulation to provide an

incentive for the development of devices for use in the treatment or diagnosis of diseases

affecting these populations. A qualifying manufacturer may submit a humanitarian device

exemption (HDE) application, which is similar in both form and content to a premarket approval

(PMA) application, but is exempt from the effectiveness requirements of a PMA.

Devices Intended for Pediatric Use. In order to encourage the development of devices for use

with children, any application for a device intended solely for pediatric use is exempt from any

fee. 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.

Applications from Federal or State Government Entities. Any application from a state or federal

government entity is exempt from any fee, unless the device is to be distributed commercially.

H.R. 2900 would include Indian tribes in the definition of government entities and thus exempt

them from paying establishment fees; S. 1082 would not.

Further Manufacturing. In order to avoid the charging of multiple fees for single devices that

have multiple manufactured components, any application for a product licenced for further

manufacturing use only is exempt from any fee.

Premarket Notification by Third Parties. Under authority created by the Food and Drug

Administration Modernization Act (P.L. 105-115), FDA has accredited third parties, authorizing

them to conduct the primary review of 510(k)s for eligible devices. The purpose of the program is

to improve the efficiency and timeliness of FDA’s 510(k) process, the process by which most

medical devices receive marketing clearance in the United States. No FDA fee is assessed for

premarket notification (510(k)) submissions reviewed by accredited third parties, although the

third parties may themselves charge a fee for their services.

Small Businesses. For FY2007 (MDUFMA, as modified by MDUFSA14), firms with annual gross

sales or receipts of $30 million or less, including the gross sales and receipts of all affiliates,

partners, and parent firms, qualify for a fee waiver for their first PMA. Firms with annual gross

sales or receipts of $100 million or less, including the gross sales and receipts of all affiliates,

partners, and parent firms, qualify for lower rates for all applications that are subject to a fee.15

The small business discounted fee schedule is important to the medical device industry;

according to GAO, the vast majority of companies that paid MDUFMA fees in 2006 qualified

as small businesses:

Of the 697 companies that qualified as small businesses under the MDUFMA user fee

program in fiscal year 2006, 656, or about 95%, had revenues at or below $30 million—the

threshold for small business qualification originally set by MDUFMA in 2002. Of the 41

MDUFSA increased the annual gross receipts or sales threshold below which businesses are eligible for reduced fees

or a waiver of fees by the Secretary.

Dan Schultz, “All-Hands Notice from Dan Schultz about MDUFA 2007,” FDA website (April 16, 2007), at

http://www.fda.gov/cdrh/mdufma/041607-letter.html.

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companies that had revenues above $30 million but at or below the current threshold of $100

million, 35 had revenues above $30 million but at or below $70 million. Of the 697

companies that qualified as small businesses in fiscal year 2006, 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 fiscal year 2006.16

MDUFA 2007 would no longer consider the assets of partners and parent firms in the small

business qualification calculation, and would further reduce the application fees paid by small

business—the majority of device manufacturers.17 For example, a small business would pay 50%

of the standard fee when it submits a 510(k), compared with 80% at present, and 25% of the

standard fee when it submits a PMA, compared with 38% at present. FDA would also continue to

provide a fee waiver for the first PMA submitted by a qualified small business applicant. In

addition, MDUFA 2007 would allow foreign businesses to qualify for small business fees and

fee waivers.

Modular PMA Refunds. Manufacturers may choose to submit to FDA the large amount of

information required in a PMA in sections, over time, in a modular PMA. In the event that a

manufacturer chooses to withdraw a modular application before FDA takes its first action on the

application or before all of the parts have been submitted, both bills provide that the Secretary

may make a partial refund of the filing fee. S. 1082 specifies that the Secretary would have the

sole authority to make refund decisions, and that such decisions would not be reviewable.

Use of Fees

According to the terms of MDUFMA, FDA may only use fees collected under MDUFMA for

specified purposes (FFDCA § 737(5)). Most of these are related to decreasing the time required

for FDA to determine whether a medical device should reach the marketplace. (See Table 9.) The

payment of a MDUFMA premarket review fee is not linked in any way to FDA’s final decision on

whether a product should reach the market. 18

Government Accountability Office, “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/

new.items/d07571r.pdf.

FDA, “Medical Device User Fee and Modernization Act; Public Meeting,” Federal Register, vol. 72, no. 74, p.

19528, (April 18, 2007) at http://frwebgate5.access.gpo.gov/cgi-bin/

waisgate.cgi?WAISdocID=268837241492+0+0+0&WAISaction=retrieve.

CDRH, “Summary of the Medical Device User Fee and Modernization Act of 2002 Including Changes Made by the

Medical Devices Technical Corrections Act (April 1, 2004),” FDA website, (November 1, 2004), p. 2, at

http://www.fda.gov/cdrh/mdufma/mdufmasummary.pdf. Visited January 22, 2007.

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Table 9. Use of MDUFMA Fees

FDA may use MDUFMA fees for the following elements of

the “process for the review of device applications”

•

premarket reviews;

•

premarket inspections;

•

monitoring of research relating to premarket reviews;

•

review of investigational new drug applications (INDs) and investigational device exemptions (IDEs);

•

monitoring of research conducted to develop INDs or IDEs;

•

development of guidance, policy documents, and regulations to improve the process for the review of

device applications;

•

development of test methods and standards applicable to premarket reviews;

•

technical assistance to applicants;

•

initial classification or reclassification of a device;

•

actions required to call for PMAs for pre-Amendments Class III devices;

•

evaluation of postmarket studies required as a condition of approval; and

•

compiling, developing, and reviewing information concerning devices subject to premarket review to identify

safety and effectiveness issues.

Source: 21 U.S.C. 379i(5); FFDCA §737(5).

MDUFA 2007 makes no change to MDUFMA’s use of fees provision. The FDA Agreement had

proposed that, as resources permit, FDA would apply user fee revenues to support reviewer

training that is related to the process for the review of devices, including training to enhance

scientific expertise. FDA would, in turn, provide summary information on the types of training

provided to staff on an annual basis.

Performance Goals

In addition to enabling the collection of user fees, MDUFMA set performance goals for FDA.

These goals were summarized in the FDA Commitment Letter, incorporated by reference in

MDUFMA (§101(3)). (See Table 10.) The performance goals, but not the letter, are also included

in the FFDCA (§738(g)(1)(A)-(D)). According to the FDA Agreement, FDA is on track to meet

nearly all of the MDUFMA performance goals, which will sunset on October 1, 2007, along with

FDA’s MDUFMA user fee authority.

For purposes of MDUFA 2007, the FDA Agreement proposes to meet fewer and more rigorous

goals that build on the progress made in MDUFMA. In making these proposals, FDA considered

efficiencies gained and expected by means of additional scientific, regulatory, and leadership

training; additional staff, including those with expertise demanded by increasingly complex

device reviews; expanded use of outside experts; and information technology improvements that

allow FDA to better track and manage the device review process.

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MDUFMA performance goals set general time tables for certain types of activities (such as PMA

reviews), but allow for some flexibility that may be prudent, given different types of PMAs and

other applications may vary in complexity. Therefore, performance goals generally state that, a

certain percentage of the time FDA will complete a particular type of activity within a given time

period (see Table 10).

Performance Goal-Setting Process

In FDA’s development of its recommendations to the Congress for FDA performance goals and

plans for meeting those goals, MDUFMA required FDA to consult with an array of governmental,

professional, and consumer groups; publish its recommendations in the Federal Register; provide

a public comment period; and hold a public meeting. MDUFA 2007 contains parallel provisions.

In addition, the Senate version of the bill, S. 1082, specifies that the recommendations are to be

revised upon consideration of public comments. Furthermore, S. 1082 would require transmittal

of the recommendations to Congress and would write the relevant consultation requirements into

the FFDCA.

Quarterly Performance Reports

The FDA Agreement specifies that FDA will report quarterly its progress toward meeting the

quantitative goals described in this letter. In addition, for all submission types, FDA will track

total time (time with FDA plus time with the company) from receipt or filing to final decision

(approval, denial, substantial equivalence [SE], or nonsubstantial equivalence [NSE]). FDA will

also provide, on an annual basis, de-identified review performance data for the branch (section of

reviewers grouped by subject-matter) with the shortest average review times and the branch with

the longest average review times for 510(k)s, 180-day supplements, and real-time supplements.

Table 10. Comparison of Quantitative Decision Performance Goals in

MDUFMA and MDUFA 2007

MDUFMA

MDUFA 2007

PMA and Panel Track Supplements

50% of PMAs and panel track PMA supplements in 180

days

60% of PMAs and panel track PMA supplements in 180

days

90% of PMAs, panel track supplements, premarket

reports in 320 days

90% of PMAs and panel track supplements in 295 days

N/A

50% of expedited PMAs and expedited panel track PMA

supplements in 180 days

90% of expedited PMAs in 300 days

90% of expedited PMAs and expedited panel track PMA

supplements in 280 days

Modular PMA

N/A

75% of PMA modules in 90 days

N/A

90% of PMA modules in 120 days

510(k)s

80% of 510(k)s in 90 days

90% of 510(k)s in 90 days

N/A

98% of 510(k)s in 150 days

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MDUFMA

MDUFA 2007

180-Day PMA Supplements

90% of 180-Day PMA supplements in 180 days

85% of 180-Day PMA supplements in 180 days

95% of 180-Day PMA supplements in 210 days

Real-Time PMA Supplements

80% of Real-Time PMA Supplements in 60 days

N/A

90% of Real-Time PMA Supplements in 90 days

Biological License Applications

90% of BLAs in 10 months

90% of BLA supplements in 10 months

Same as MDUFMA

90% of BLA resubmissions and BLA supplement

resubmissions in 2 months

Source: FDA, “Comparison of Quantitative Decision Goals in MDUFMA and II,” CDRH website,(Updated

April 16, 2007) at http://www.fda.gov/cdrh/mdufma/mdufmaii-comparison.html.

Accredited Third-Party Inspections

Accredited third-party inspections were introduced in MDUFMA (as amended by MDTCA) with

the goal of reducing the burden on FDA inspectors by enabling FDA-accredited persons (third

parties) to conduct certain inspections on FDA’s behalf. FDA is required, by statute, to inspect

certain domestic establishments where medical devices are manufactured at least once every two

years. According to the GAO, FDA has not been meeting this requirement.19 Instead, five or six

years sometimes pass between FDA inspections at any one establishment.

GAO reports that FDA accredited the first third party on March 11, 2004. As of October 31, 2006,

of 23 organizations that had applied to conduct third-party inspections of establishments, 16 had

received FDA accreditation, and seven had completed the necessary training and were cleared to

conduct independent inspections. As of October 31, 2006, two accredited organizations had

conducted independent inspections—one inspection of a domestic establishment and one

inspection of a foreign establishment. During that same period, 36 inspections of domestic

establishments and one inspection of a foreign establishment were conducted by accredited

organizations jointly with FDA officials as part of training that FDA requires of accredited

organizations. These 38 inspections represent just over 1% of the 3,470 inspections that FDA

reported to GAO it conducted between March 11, 2004, and October 31, 2006.20

GAO reports that several factors may influence manufacturers’ interest in voluntarily requesting

an inspection by an accredited organization:

According to FDA and representatives of affected entities, there are potential incentives and

disincentives to requesting an inspection, as well as reasons for deferring participation in the

Government Accountability Office, “Medical Devices: Status of FDA’s Program for Inspections by Accredited

Organizations,” Report to Congress GAO-07-157 (January 2007).

This number includes both postmarket quality system inspections of domestic establishments where a Class II or III

medical device was manufactured, and inspections of foreign medical device establishments.

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program. Potential incentives include the opportunity to reduce the number of inspections

conducted to meet FDA and other countries’ requirements and to control the scheduling of

the inspection. Potential disincentives include bearing the cost for the inspection and

uncertainty about the potential consequences of making a commitment to having an

inspection to assess compliance with FDA requirements in the near future. Some

manufacturers might be deferring participation. For example, manufacturers that already

contract with a specific accredited organization to conduct inspections to meet the

requirements of other countries might defer participation until FDA has cleared that

organization to conduct independent inspections.21

MDUFA 2007 would change the third-party accredited person inspection program in three major

areas. According to the FDA Agreement, the proposals are intended to increase the quantity of

useful information FDA has about the compliance status of medical devices marketed in the

United States and to permit FDA to focus its inspectional resources on those firms and products

posing the greatest risk to public health.

The first change would be to streamline the administrative burdens associated with qualifying for

the program. For example, rather than having to petition FDA for clearance to use a third party,

the proposal would require only that firms provide FDA with 30 days prior notice of their intent

to use a third party listed on FDA’s website.

The second change would be to expand participation in the program. For example, the current

third-party program restricts qualified manufacturers of Class II and Class III medical devices to

two consecutive third-party inspections, after which FDA must conduct the next inspection,

unless the manufacturer petitions and receives a waiver. MDUFA 2007 would permit firms to use

third parties for an unlimited number of consecutive inspections without seeking a waiver.

However, FDA would continue to conduct “for cause” or follow-up inspections whenever it

deemed such inspections appropriate.

The third change would be to permit device companies to voluntarily submit to FDA reports by

third parties assessing conformance with an appropriate international quality systems standard,

such as those set by the International Standards Organization. FDA would consider the

information in these reports in setting its inspection priorities.

Reprocessed Single-Use Devices

Some reprocessed SUDs are relatively simple items for external use, such as inflatable sleeves to

improve blood circulation, while others are complex and invasive, such as catheters that are

inserted into the heart to monitor cardiac functioning. According to a GAO report issued in 2000

(prior to MDUFMA), some devices, both SUDs and those marketed as reusable, had been

reprocessed in-house by hospitals and other treatment facilities, while others had been

reprocessed by companies formed for that purpose. 22 At that time, the practice of SUD

reprocessing raised public health concerns, primarily regarding the potential risks of infection and

Government Accountability Office, “Medical Devices: Status of FDA’s Program for Inspections by Accredited

Organizations,” Report to Congress GAO-07-157 (January 2007).

General Accounting Office, “Single-Use Medical Devices: Little Available Evidence of Harm From Reuse, but

Oversight Warranted,” GAO/HEHS-00-123 (June 2000), at http://frwebgate.access.gpo.gov/cgi-bin/

useftp.cgi?IPaddress=162.140.64.21&filename=he00123.pdf&directory=/diskb/wais/data/gao.

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device malfunction, and led to complaints by the original device manufacturers that FDA had not

maintained consistent regulatory standards for different types of medical device companies.

Before MDUFMA, the regulatory requirements for manufacturers of reprocessed single-use

devices basically depended upon the class of the device. Manufacturers of reprocessed Class I

and II single-use devices were required to have a 510(k), unless the device was exempt from

510(k). Reprocessors of Class III devices were required to obtain premarket approval. MDUFMA

made reprocessors of some previously exempt devices no longer exempt from the 510(k)

submission requirements. It required reprocessors to submit 510(k)s that include validation data.

Validation data were also required for many reprocessors of single-use devices that were

previously the subject of cleared 510(k)s. Finally, reprocessors of Class III devices needed to

submit a premarket report (a new type of PMA) to FDA.

MDUSFA added the requirement that an SUD would be deemed as misbranded (and thus not

legally marketable in the United States) unless it identified the manufacturer. MDUFSA allowed

such information to be provided by a detachable label intended to be affixed to the medical record

of a patient.

MDUFA 2007 does not focus on SUDs, but does contain a requirement that SUD reprocessors

pay the proposed annual establishment fee.

Other MDUFA 2007 Provisions

In addition to the above provisions, as described below, MDUFA 2007 would require the

production of several annual reports, and H.R. 2900 would authorize appropriations for

postmarket surveillance and would require a study of nosocomial infections (those acquired in

hospitals) related to medical devices.

Annual Reports

MDUFMA requires the Secretary to submit annual progress reports to relevant congressional

committees regarding the progress of FDA in achieving fee-related performance goals specified

in a letter from the Secretary, and regarding the implementation of the authority to collect such

fees. H.R. 2900 would continue this requirement and specifies that the implementation report

should include a description of the use of such fees for postmarket safety activities. S. 1082

would also continue the requirement, but instead of requiring that a description of postmarket

safety activities be included in the implementation report, it would require the inclusion of

information on all previous cohorts for which the Secretary has not given a complete response on

all device premarket applications, supplements, and premarket notifications in the cohort. S. 1082

would also require that performance goal and implementation reports be made available to the

public. In addition, unlike MDUFMA and H.R. 2900, S. 1082 would write the report

requirements into the FFDCA.

Postmarket Safety Appropriations Authorization

MDUFMA contained two provisions related to postmarket reviews (§104). One, a provision that

will cease to be effective on October 1, 2007, authorized additional appropriations for postmarket

surveillance—$3 million for FY2003, $6 million for FY2004, and “such sums as may be

necessary” in subsequent years. These sums were not appropriated. The second provision

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required the HHS Secretary to conduct a study of the postmarket review impact of the medical

device user-fee program. MDUFMA also specified that user fees may fund the evaluation of

postmarket studies if they are required as a condition of approval. (FFDCA §737(5)(J)).

According to FDA, MDUFMA focused on premarket review activities, largely limiting FDA’s use

of MDUFMA funds to this area, and focusing all performance goals on it as well. This emphasis

on premarket activities raised some questions regarding whether this focus might have a negative

impact on the postmarket and enforcement activities.

Measuring the impact of MDUFMA on enforcement activities is not a straightforward endeavor,

and is beyond the scope of this report. For example, while one set of metrics (the number of

CRDH warning letters issued each year since FY2000) shows that a decrease in the number of

letters coincides with the start of MDUFMA, coincidence in time does not prove cause and effect.

As is shown in Table 11, the recent decline in warning letters is due to a change in policy related

to the Mammography Quality Standards Act (MQSA, P.L. 102-539).23

H.R. 2900 contains a different requirement relating to postmarket safety. It authorizes additional

appropriations for FY2008-FY2012 of such sums as may be necessary for the purpose of

collecting, developing, reviewing, and evaluating postmarket safety information on medical

devices. S. 1082 contains no parallel provision in the medical device user fee title.

Table 11. CDRH Warning Letters Issued in Total and

Under the MQSA, FY2000-FY2007

Non-MQSA

MQSA

Total

FY2000

191

337

528

FY2001

105

393

498

FY2002

206

285

FY2003

121

205

FY2004

193

198

FY2005

177

182

FY2006

149

154

FY2007a

Source: FDA Office of Legislation.

Note: According to FDA’s Office of Legislation, the number of MQSA warning letters has significantly decreased

because of a change in ORA and CDRH policy. Enforcement strategies for violations of the MQSA now focus on

opportunities for correction and re-inspections (fees paid by facilities) prior to issuing warning letters. These

measures have reduced the number of warning letters the program has had to issue.

Partial year, through February 1, 2007.

For more information about CDRH enforcement statistics, see the CDRH Charts in FDA Office of Enforcement,

Office of Regulatory Affairs, “The Enforcement Story,” (FY2006), at http://www.fda.gov/ora/about/enf_story/ch2/

cdrh_charts.pdf.

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Nosocomial Infections

H.R. 2900 would define nosocomial infection as an infection that is acquired while an individual

is a patient at a hospital and was neither present nor incubating in the patient prior to receiving

services in the hospital. The bill would require the Comptroller General to conduct and deliver to

Congress a study on the number of nosocomial infections attributable to new and reused medical

devices and the causes of such infections. S. 1082 contains no parallel provisions.

Other MDUFMA Provisions

MDUFMA contained several provisions that have not been raised in MDUFA 2007 proposals:

•

The review of combination products (products that combine elements of devices,

drugs, or biologics) was to be coordinated by a new office in the Office of the

Commissioner.

•

Electronic labeling was authorized for prescription devices intended to be used in

health care facilities.

•

The sunset provision applicable to intended use based upon labeling

(§513(i)(1)(E)) was revoked.

•

MDUFMA explicitly provided for modular review of PMAs.

•

New provisions were added concerning devices intended for pediatric use.

•

GAO and NIH were directed to prepare reports concerning breast implants.

•

The manufacturer of a device was required to be identified on the device itself,

with certain exceptions.

FDA Agreement Recommendations not in MDUFA 2007

While MDUFA 2007 generally followed the terms of the proposals made in the FDA

Agreement, there were some topics covered in the Agreement that are not covered by MDUFA

2007. Their absence from the legislation does not preclude FDA from following the terms of

the recommendations.

Interactive Review

The FDA Agreement proposes that FDA continue to incorporate an interactive review process to

provide for, and encourage, informal communication between FDA and sponsors to facilitate

timely completion of the review process based on accurate and complete information. Interactive

review entails responsibilities for both FDA and sponsors. Interactive review is intended to: (a)

prevent unnecessary delays in the completion of the review; (b) avoid surprises to the sponsor at

the end of the review process;(c) minimize the number of review cycles and the extent of review

questions conveyed through formal requests for additional information; and (d) ensure timely

responses from sponsors.

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Guidance Document Development

The FDA Agreement proposes that FDA continue to develop guidance documents to the extent

possible without adversely impacting the review timeliness for MDUFMA-related submissions.

In addition, FDA would post a list of guidance documents it is considering for development and

provide stakeholders an opportunity to provide comments and/or draft language for those topics

as well as suggestions for new or different guidances.

Diagnostic Imaging Products

Diagnostic imaging devices (e.g., CT scans) that are sometimes used concurrently with diagnostic

drug and biological products (e.g., contrast agents and radiopharmaceuticals)—so-called

“concomitant use products”—present important questions of efficient regulation and consultation

between product Centers that are similar to those raised by combination products. In response to

these concerns, the FDA Agreement proposes that FDA develop a guidance document to ensure

timely and effective review of, and consistent, appropriate postmarket regulation and product

labeling requirements for, diagnostic imaging devices used with approved imaging contrast

agents and/or radiopharmaceuticals. FDA proposes to publish draft guidance by the end of

FY2008 and allow for a 90-day public comment period. FDA proposes to issue a final guidance

within one year of the close of the comment period.

In Vitro Diagnostics (IVDs)

To facilitate the development of IVD devices (lab tests), the FDA Agreement proposes that FDA

continue to explore ways to clarify regulatory requirements and to reduce regulatory burden, as

appropriate. FDA proposes to:

•

Draft or revise guidance on the conduct of clinical trials involving deidentified

leftover specimens, clinical trial design issues for molecular diagnostic tests,

migration studies, herpes simplex virus, enterovirus, and influenza testing;

•

Conduct a pilot program to evaluate integrating the 510(k) review and Clinical

Laboratory Improvement Amendments (CLIA, (42 U.S.C. 263a) waiver review

processes for possible increased efficiencies. This pilot would include only

voluntary participants from industry, and the applications involved in the pilot

would not be counted toward the MDUFA 2007 performance goals;

•

Consider industry proposals on acceptable CLIA waiver study protocols, develop

acceptable protocol designs, and make them available by adding appendices to

the guidance or by posting redacted protocols on the Office of In Vitro

Diagnostic Device (OIVD) website;

•

Track and report FDA performance on CLIA waiver applications and share this

information with industry annually and then evaluate, at the end of year two,

whether user fees and performance goals for CLIA waivers should be considered

for MDUFA 2007I;

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•

Review an industry-provided list of Class I and II low risk IVD devices to

determine if any could be exempted from premarket notification and allow

interested parties to petition for exemptions consistent with 510(m)(2)

[provisions exempting certain devices from 510(k) premarket notification

requirements]; and

•

Conduct a review of the pre-IDE program to address issues raised by industry.

Meetings

The FDA Agreement proposes that FDA make every effort to schedule informal and formal

meetings, both before and during the review process, in a timely way, and industry would

make every effort to provide timely and relevant information to make the meetings as productive

as possible.

Congressional Research Service

Medical Device User Fee and Modernization Act (MDUFMA) Reauthorization

Appendix. Acronyms Used in This Report

510(k)

Premarket Notification

513(g)

Request for Information About Device Classification

BLA

Biological License Application

CBER

Center for Biologics Evaluation and Research

CDRH

Center for Devices and Radiological Health

CLIA

Clinical Laboratory Improvement Amendments (42 U.S.C. 263a)

FDA

United States Food and Drug Administration

FFDCA

Federal Food, Drug and Cosmetic Act (21 U.S.C., Chapter 9)

FTE

Full Time Equivalent Employee

GAO

Government Accountability Office (formerly General Accounting Office)

GMP

Good Manufacturing Practice

HHS

United States Department of Health and Human Services

HUD

Humanitarian Use Device

IDE

Investigational Device Exemption

IND

Investigational New Drug Application

IVD

In Vitro Diagnostic Device (Laboratory Diagnostic Test)

MDTCA

Medical Device Technical Corrections Act (P.L. 108-214)

MDUFMA

Medical Device User Fee and Modernization Act (P.L. 107-250)

MDUFA 2007

Medical Device User Fee and Modernization Act, 2007 Reauthorization

MQSA

Mammography Quality Standards Act (P.L. 102-539)

MUDFSA

Medical Device User Fee Stabilization Act of 2005 (P.L. 109-43)

NSE

Non-Substantial Equivalence

OIVD

Office of In Vitro Diagnostic Device

PDP

Product Development Protocol

PDUFA

Prescription Drug User Fee Act

Public Law

PMA

Premarket Approval

Substantial Equivalence

SUD

Single-Use Device

USC

United States Code

Author Contact Information

(name redacted)

Specialist in Public Health and Bioethics

[redacted]@crs.l oc.gov, 7-....

Congressional Research Service

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