Union Calendar No. 413

103D CONGRESS

2D SESSION H. R. 4864

[Report No. 103–751]

A BILL

To amend the Federal Food, Drug, and Cosmetic

other purposes.Act to authorize a device application fee, and for

SEPTEMBER 26, 1994

Reported with an amendment, committed to the Commitordered to be printed tee of the Whole House on the State of the Union, and
IB

Union Calendar No. 413

103D CONGRESS

2D SESSION H. R. 4864

[Report No. 103–751]

To amend the Federal Food, Drug, and Cosmetic Act to authorize a device

application fee, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

AUGUST 1, 1994

Mr. WAXMAN (for himself and Mr. DINGELL) introduced the following bill;

which was referred to the Committee on Energy and Commerce

SEPTEMBER 26, 1994

Reported with an amendment, committed to the Committee of the Whole

House on the State of the Union, and ordered to be printed

[Strike out all after the enacting clause and insert the part printed in italic]

[For text of introduced bill, see copy of bill as introduced on August 1, 1994]

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to

authorize a device application fee, and for other purposes.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE AND REFERENCE.

4 (a) SHORT TITLE.—This Act may be cited as the

5 ‘‘Medical Device User Fee Act of 1994’’.
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1 (b) REFERENCE.—Whenever in this Act an amend2 ment or repeal is expressed in terms of an amendment to,

3 or repeal of, a section or other provision, the reference shall

4 be considered to be made to a section or other provision

5 of the Federal Food, Drug, and Cosmetic Act.

6 SEC. 2. FINDINGS.

7 The Congress finds that—

8 (1) prompt approval and clearance of safe and

9 effective devices is critical to the improvement of the

10 public health so that patients may enjoy the benefits

11 of devices to diagnose, treat, and prevent disease;

12 (2) the public health will be served by furnishing

13 additional funds for the review of devices so that

14 statutorily mandated deadlines may be met, and

15 (3) the fees authorized by the amendment made

16 by section 3 will be dedicated—

17 (A) toward expediting the review of device

18 applications, supplements, and substantial

19 equivalence submissions, and

20 (B) for related activities as defined in the

21 amendment,

22 as set forth in goals identified in the letter of July 8,

23 1994, from the Commissioner of Food and Drugs to

24 the Committee on Energy and Commerce of the House

25 of Representatives.
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1 SEC. 3. FEES RELATING TO DEVICES.

2 Chapter VII is amended by adding at the end of sub3 chapter C the following:

4 ‘‘PART 3—FEES RELATING TO DEVICES

5 ‘‘SEC. 741. DEFINITIONS.

6 ‘‘For purposes of this subchapter:

7 ‘‘(1) The term—

8 ‘‘(A) ‘device application’ means an applica9 tion for approval of a device submitted under

10 section 515(c) or section 351 of the Public Health

11 Service Act, a supplement to such an applica12 tion, or a submission for a device made under

13 section 510(k) claiming the devise is substan14 tially equivalent as described in section

15 513(f)(1)(A) (in this part referred to as a ‘device

16 substantial equivalence submission’); and

17 ‘‘(B) ‘section 351 application’ means a de18 vice application submitted under section 351 of

19 the Public Health Service Act.

20 ‘‘(2) The term ‘supplement’ means a request to

21 the Secretary to approve a change in a device appli22 cation which has been approved under section 515(d)

23 or section 351 of the Public Health Service Act.

24 ‘‘(3) The term ‘process for the review of device

25 applications and related activities’ means the follow-
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1 ing activities of the Secretary with respect to the re2 view of device applications and related activities:

3 ‘‘(A) The activities necessary for the review

4 of device applications and related activities.

5 ‘‘(B) The issuance of action letters which

6 allow marketing of devices or which set forth in

7 detail the specific deficiencies in such applica8 tions and, where appropriate, the actions nec9 essary to place such applications in condition for

10 approval.

11 ‘‘(C) The inspection of device establishments

12 and other facilities undertaken as part of the

13 Secretary’s review of pending device applica14 tions.

15 ‘‘(D) Any activity necessary for the review

16 of applications for licensure of devices subject to

17 section 351 of the Public Health Service Act, for

18 the licensure of establishments where such devices

19 are manufactured, and for the release of lots of

20 such devices.

21 ‘‘(E) Review of device applications for an

22 investigational new drug exemption under sec23 tion 505(i) and for an investigational device ex24 emption under section 520(g) and activities con-
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1 ducted in anticipation of the submission of an

2 application under sections 505(i) and 520(g).

3 ‘‘(F) The development of guidance and pol4 icy documents to improve the process for the re5 view of device applications.

6 ‘‘(G) The development of test methods and

7 standards in connection with the review of device

8 applications and related activities.

9 ‘‘(H) The provision of technical assistance

10 to device manufacturers in connection with the

11 submission of a device application.

12 ‘‘(I) Any activity undertaken in connection

13 with the export of a device.

14 ‘‘(J) Any activity undertaken under sections

15 513 and 515(i) in connection with the initial

16 classification and reclassification of a device and

17 under section 515(b) in connection with any re18 quirement for premarket approval of a device.

19 ‘‘(K) Monitoring of research on devices.

20 ‘‘(L) Any activities undertaken under sec21 tions 519(a) and 519(b).

22 ‘‘(M) Postmarket studies required as a con23 dition of an approval of a device application

24 under section 515(d) or section 351 of the Public

25 Health Service Act.
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1 ‘‘(N) Postmarket surveillance required

2 under section 522.

3 ‘‘(4) The term ‘costs of resources allocated for the

4 process for the review of device applications and re5 lated activities’ means the expenses incurred in con6 nection with the process for the review of device appli7 cations and related activities for—

8 ‘‘(A) officers and employees of the Food and

9 Drug Administration, employees under contract

10 with the Food and Drug Administration, advi11 sory committees, and costs related to such offi12 cers, employees, and committees,

13 ‘‘(B) management of information, and the

14 acquisition, maintenance, and repair of com15 puter resources,

16 ‘‘(C) leasing, maintenance, renovation, and

17 repair of facilities and acquisition, maintenance,

18 and repair of fixtures, furniture, scientific equip19 ment, and other necessary materials, services,

20 and supplies, and

21 ‘‘(D) collection fees under section 742 and

22 accounting for resources allocated for the review

23 of device applications and related activities, in24 cluding activities related to the review of appli-
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1 cations for fee exceptions, waivers, and reduc2 tions.

3 ‘‘(5) The term ‘adjustment factor’ applicable to a

4 fiscal year is the lower of—

5 ‘‘(A) the Consumer Price Index for all

6 urban consumers (all items; United States city

7 average) for August of the preceding fiscal year

8 divided by such Index for August 1994, or

9 ‘‘(B) the total budget authority provided for

10 discretionary programs for the immediately pre11 ceding fiscal year (as reported in the Office of

12 Management and Budget sequestration preview

13 report, if available, required under section

14 254(d) of the Balanced Budget and Emergency

15 Deficit Control Act of 1985) divided by such

16 budget authority for fiscal year 1994 (as re17 ported in the Office of Management and Budget

18 final sequestration report submitted after the end

19 of the 103d Congress, 2d Session).

20 The term ‘budget authority’ in subparagraph (B) is

21 as defined in section 3(2)(A) of the Balanced Budget

22 and Emergency Deficit Control Act of 1985 (2 U.S.C.

23 622(2)(A)), as in effect as of January 1, 1994.
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1 ‘‘SEC. 742. AUTHORITY TO ASSESS AND USE DEVICE USER

2 FEES.

3 ‘‘(a) FEES.—Beginning in fiscal year 1995, the Sec4 retary shall assess and collect fees as follows:

5 ‘‘(1) GENERAL RULE.—Except as provided in

6 paragraph (2), each person that submits, on or after

7 90 days before the date of the enactment of the first

8 appropriation under subsection (g)(4) for fees under

9 this section, a device application shall be subject, in

10 accordance with paragraph (3), to the fee prescribed

11 by subsection (b). Before April 30, 1995, the Secretary

12 shall establish guidelines for the combination of mul13 tiple device applications in those situations where it

14 is appropriate to combine the applications and assess

15 a single fee. A single fee shall be assessed upon an ap16 plication which is such a combination.

17 ‘‘(2) EXCEPTION.—

18 ‘‘(A) FURTHER MANUFACTURING USE.—No

19 fee shall be required for the submission of a sec20 tion 351 application for a product licensed for

21 further manufacturing use only.

22 ‘‘(B) PREVIOUSLY FILED APPLICATION OR

23 SUPPLEMENT.—If a device application was—

24 ‘‘(i) submitted by a person that paid

25 the fee for such application,

26 ‘‘(ii) accepted for filing, and
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1 ‘‘(iii) not approved or withdrawn

2 (without a waiver under subsection (d)),

3 the submission of a device application for the

4 identical device by the same person (or the per5 son’s licensee, assignee, or successor) shall not be

6 subject to a fee under paragraph (1).

7 ‘‘(3) PAYMENT SCHEDULE.—

8 ‘‘(A) GENERAL RULE.—Except as provided

9 in subparagraph (B)—

10 ‘‘(i) in the case of an application sub11 mitted under section 515(c), an application

12 for a device submitted under section 351 of

13 the Public Health Service Act, or a supple14 ment submitted with required clinical data,

15 15 percent of the fee prescribed by sub16 section (b) shall be due upon submission of

17 such application or supplement and the re18 mainder within 30 days of receipt of notice

19 from the Secretary of acceptance of such ap20 plication or supplement for filing or review,

21 and

22 ‘‘(ii) in the case of the submission of a

23 supplement for which clinical data are not

24 required or a submission under section

25 510(k), the fee prescribed under subsection
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1 (b) shall be due within 30 days of receipt of

2 notice from the Secretary of acceptance of

3 such supplement or submission for filing or

4 review.

5 ‘‘(B) EXCEPTIONS.—

6 ‘‘(i) PENDING APPLICATIONS.—In the

7 case of a device application for which fees

8 are required under paragraph (1) and

9 which is pending on the date of the enact10 ment of the first appropriation under sub11 section (g)(4) for fees under this section, the

12 fee required by paragraph (1) shall be due

13 90 days after such date of enactment.

14 ‘‘(ii) EXCESS OF AUTHORIZATION.—A

15 fee which is due after an amount of fees

16 equal to the authorization of appropriations

17 under subsection (g)(4) for the fiscal year in

18 which the fee is imposed has been collected

19 shall be due on November 1 in the following

20 fiscal year.

21 ‘‘(b) FEE AMOUNTS.—

22 ‘‘(1) AMOUNT.—Except as provided in para23 graph (2) and subject to subsections (c), (d), (f), and

24 (g)(3)(A), the fees required under subsection (a) are as

25 follows:
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1 ‘‘(A) $52,000 for an application for a device

2 submitted under section 515(c) or under section

3 351 of the Public Health Service Act.

4 ‘‘(B) $7,100 for a supplement for which

5 clinical data are required.

6 ‘‘(C) $4,500 for a supplement for which

7 clinical data are not required.

8 ‘‘(D) $3,200 for a device substantial equiva9 lence submission under section 510(k).

10 ‘‘(2) SMALL BUSINESS EXCEPTION.—

11 ‘‘(A) APPLICATIONS AND SUBMISSIONS.—

12 Any person employing fewer than 20 employees,

13 including employees of affiliates, which does not

14 have a device introduced or delivered for intro15 duction into interstate commerce under a device

16 application—

17 ‘‘(i) shall pay one-half the amount of

18 the fee prescribed by paragraph (1)(A) one

19 year after the date of final action by the

20 Secretary on an application of such person

21 which is subject to such fee, and

22 ‘‘(ii) shall pay the fee prescribed by

23 paragraph (1)(D) for a submission made by

24 such person under section 510(k) one year
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1 after the date of final action by the Sec2 retary on such submission.

3 ‘‘(B) CERTIFICATION.—The Secretary shall

4 require any person who applies to pay a fee in

5 accordance with subparagraph (A) to certify

6 such person’s qualification under such subpara7 graph. The Secretary shall periodically publish

8 in the Federal Register a list of persons making

9 such certification.

10 ‘‘(C) DEFINITION.—For purposes of this

11 paragraph, a person is an affiliate of another

12 person when—

13 ‘‘(i) one person controls, or has the

14 power to control, directly or indirectly, the

15 other person,

16 ‘‘(ii) a third party controls, or has the

17 power to control, directly or indirectly, both

18 persons, or

19 ‘‘(iii) an identity of interest between or

20 among such persons exists such that affili21 ation may be found.

22 ‘‘(c) ADJUSTMENTS.—

23 ‘‘(1) FEE ADJUSTMENT.—Subject to the amount

24 appropriated for a fiscal year under subsection (g)(4),

25 the Secretary shall, in each fiscal year beginning after
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1 fiscal year 1995, adjust the fees due in the fiscal year

2 following the fiscal in which the adjustment is made

3 to reflect the greater of—

4 ‘‘(A) the total percentage increase that oc5 curred during the preceding fiscal year in the

6 Consumer Price Index for all urban consumers

7 (all items; United States city average) that ex8 ceeds 3.5 percent, or

9 ‘‘(B) the total percentage increase for such

10 preceding fiscal year in basic pay under the

11 General Schedule in accordance with section

12 5332 of title 5, United States Code, as adjusted

13 by any locality-based comparability payment

14 pursuant to section 5304 of such title for Federal

15 employees stationed in the District of Columbia

16 that exceeds 3.5 percent.

17 The Secretary shall, by notice published in the Fed18 eral Register, make an adjustment under this para19 graph before December 1 of each year.

20 ‘‘(2) LIMIT.—The total amount of fees charged,

21 as adjusted under paragraph (1), for a fiscal year

22 may not exceed the total costs for such fiscal year for

23 the resources allocated for the process for the review

24 of device applications and related activities.
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1 ‘‘(d) FEE WAIVER OR REDUCTION.—The Secretary

2 shall grant a waiver from or a reduction of a fee for a per3 son under subsection (a) if the person has submitted an ap4 plication under section 515(c) or section 351 of the Public

5 Health Service Act and if the Secretary finds—

6 ‘‘(1) that such application is a device applica7 tion for a device which has a humanitarian device ex8 emption under section 520(m), or

9 ‘‘(2)(A) such waiver or reduction is necessary to

10 protect the public health, and

11 ‘‘(B) the assessment of the fee would present a

12 significant barrier to innovation because of limited

13 resources available to such person or other cir14 cumstances.

15 ‘‘(e) EFFECT OF FAILURE TO PAY FEES.—A device

16 application or supplement submitted by a person subject

17 to fees under subsection (a) shall be considered incomplete

18 and shall not be accepted for review by the Secretary until

19 all fees owed by such person under subsection (a) have been

20 paid. The Secretary may discontinue review of any device

21 application submitted by a person if such person has not

22 paid all fees owed under subsection (a).

23 ‘‘(f) ASSESSMENT OF FEES.—
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1 ‘‘(1) LIMITATION.—Fees may not be assessed

2 under subsection (a) for a fiscal year beginning after

3 fiscal year 1995 unless—

4 ‘‘(A) appropriations for salaries and ex5 penses of the Food and Drug Administration for

6 such fiscal year (excluding the amount of fees

7 appropriated under chapter 7 of this Act, chap8 ter 97 of title 31, United States Code, or other

9 authority for such fiscal year) are equal to or

10 greater than the amount of appropriations for

11 the salaries and expenses of the Food and Drug

12 Administration for fiscal year 1994 (excluding

13 the amount of fees appropriated under chapter 7

14 of this Act, chapter 97 of title 31, United States

15 Code, or other authority for such fiscal year)

16 multiplied by the adjustment factor applicable to

17 the fiscal year involved, and

18 ‘‘(B) the number of full-time equivalent po19 sitions at the Food and Drug Administration for

20 such year, whose salary is not paid for by fees

21 authorized under this section, is equal to or

22 greater than the number of full-time equivalent

23 positions during fiscal year 1994 multiplied by

24 the employee adjustment factor. For purposes of

25 this paragraph, the term ‘employee adjustment
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1 factor’ applicable to a fiscal year is the number

2 of full-time equivalent positions for such fiscal

3 year permitted under section 5(b) of the Federal

4 Workforce Restructuring Act of 1994 (5 U.S.C.

5 3101 note) divided by the number of such posi6 tions for fiscal year 1994.

7 ‘‘(2) AUTHORITY.—If the Secretary does not as8 sess fees under subsection (a) during any portion of

9 a fiscal year because of paragraph (1) and if at a

10 later date in such fiscal year the Secretary is author11 ized to assess such fees, the Secretary may assess and

12 collect such fees, without any modification in the rate

13 to account for the time during which the Secretary

14 could not collect such fees.

15 ‘‘(g) CREDITING AND AVAILABILITY OF FEES.—

16 ‘‘(1) IN GENERAL.—Fees collected for a fiscal

17 year pursuant to subsection (a) shall be deposited in

18 an escrow account established by the Secretary of

19 Health and Human Services and shall be available

20 and credited to the appropriation account for salaries

21 and expenses of the Food and Drug Administration as

22 provided in paragraph (2)(A), and shall be available

23 in accordance with appropriation Acts until ex24 pended, without fiscal year limitation.

25 ‘‘(2) USE OF FUNDS.—
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1 ‘‘(A) ESCROW.—

2 ‘‘(i) 15 PERCENT.—15 percent of the

3 fee assessed for the submission of an appli4 cation under section 515(c), an application

5 for a device under section 351 of the Public

6 Health Service Act, or a supplement with

7 required clinical data shall be immediately

8 available upon receipt by the Secretary.

9 ‘‘(ii) 35 PERCENT.—35 percent of the

10 fee assessed on an application or supple11 ment described in clause (i) shall be avail12 able upon receipt of the fee after acceptance

13 of such application or supplement for filing.

14 ‘‘(iii) 50 PERCENT.—50 percent of the

15 fee assessed on an application or supple16 ment described in clause (i) shall be avail17 able upon completion of a comprehensive

18 substantive review of such application or

19 supplement.

20 ‘‘(iv) OTHER SUPPLEMENTS AND SUB21 MISSIONS.—50 percent of the fee assessed for

22 the submission of a supplement for which

23 clinical data are not required or a submis24 sion under section 510(k) shall be imme25 diately available upon receipt by the Sec-
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1 retary and the remainder of such fee shall

2 be available upon completion of a com3 prehensive, substantive review of the supple4 ment or submission.

5 ‘‘(v) INTEREST ON ESCROW.—The

6 amount of interest which may accrue on

7 fees in the escrow account established under

8 paragraph (1) shall be paid into the Gen9 eral Fund of the Treasury.

10 ‘‘(B) LIMIT ON AVAILABILITY.—Not more

11 than 5 percent of the projected fee receipts in

12 any fiscal year may be used for activities de13 scribed in subparagraphs (L) and (N) of section

14 741(3), except that up to 15 percent of the pro15 jected fee receipts in any fiscal year may be used

16 for such activities after the Commissioner of the

17 Food and Drug Administration issues a public

18 notice that the Food and Drug Administration

19 has met the applicable goals referenced in section

20 2(3) of the Medical Device User Fee Act of 1994.

21 If subsequent to such public notice the Food and

22 Drug Administration is not meeting such

23 goals—
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1 ‘‘(i) the Commissioner shall issue a

2 public notice of the Food and Drug Admin3 istration’s actual performance level, and

4 ‘‘(ii) not more than 5 percent of pro5 jected fee receipts may be used for such ac6 tivities until the Commissioner issues a sub7 sequent notice that the Food and Drug Ad8 ministration is again meeting such goals.

9 ‘‘(3) COLLECTIONS AND APPROPRIATION ACTS.—

10 The fees authorized by this section—

11 ‘‘(A) shall be collected in each fiscal year in

12 an amount equal to the amount specified in ap13 propriation Acts for such fiscal year, and

14 ‘‘(B) shall only be collected and available to

15 defray increases in the costs of the resources allo16 cated for the process for the review of device ap17 plications and related activities (including in18 creases in such costs for an additional number of

19 full-time equivalent employees in the Department

20 of Health and Human Services to be engaged in

21 such process) over such costs for fiscal year 1994

22 multiplied by the adjustment factor.

23 ‘‘(4) AUTHORIZATION OF APPROPRIATIONS.—

24 There are authorized to be appropriated for fees under

25 this section—
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1 ‘‘(A) $23,000,000 for fiscal year 1995,

2 ‘‘(B) $21,300,000 for fiscal year 1996,

3 ‘‘(C) $23,000,000 for fiscal year 1997,

4 ‘‘(D) $24,000,000 for fiscal year 1998, and

5 ‘‘(E) $24,000,000 for fiscal year 1999,

6 as adjusted to reflect the percentage adjustment of fees

7 authorized under subsection (c)(1).

8 ‘‘(h) COLLECTION OF UNPAID FEES.—In any case

9 where the Secretary does not receive payment of a fee for

10 a pending application assessed under subsection (a) within

11 30 days after it is due, such fee shall be treated as a claim

12 of the United States Government subject to subchapter II

13 of chapter 37 of title 31, United States Code.

14 ‘‘(i) POSITIONS.—Any employee whose salary is paid

15 for by fees authorized under this section shall not be in16 cluded in calculating any limit on full-time equivalent posi17 tions or the grade levels for such positions.’’.

18 SEC. 4. ANNUAL REPORTS.

19 (a) FIRST REPORT.—Within 90 days after the end of

20 each fiscal year during which fees are collected under part

21 3 of subchapter C of chapter VII of the Federal Food, Drug,

22 and Cosmetic Act, the Secretary of Health and Human

23 Services shall submit a report stating the Food and Drug

24 Administration’s progress in achieving the goals identified

25 in section 2(3) of this Act during such fiscal year and the
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1 Food and Drug Administration’s future plans for meeting

2 such goals. There shall be included in such report—

3 (1) a specific statement from the Secretary con4 cerning the Food and Drug Administration’s actions

5 to reduce the backlog in the review of device applica6 tions and meeting statutory review times applicable

7 to submissions for devices, and

8 (2) the following data from the Center for De9 vices and Radiological Health and the Center for Bio10 logics Evaluation and Research:

11 (A) The number of device submissions found

12 not fileable.

13 (B) Total elapsed time for review of device

14 submissions.

15 (C) Total time for review of device submis16 sions as calculated by such Center.

17 (D) The number of negative decisions for

18 device submissions.

19 (E) The number of non-approveable letters

20 for device submissions.

21 (F) The number of deficiency letters for de22 vice submissions.

23 (G) The total number of device applications

24 by type of application.
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1 (H) The number of device applications

2 withdrawn by the sponsor.

3 (I) The number of major amendments to de4 vice applications and the number of device ap5 plications subject to post-market requirements es6 tablished as a condition of approval of a device

7 application.

8 (J) The number of devices with post-ap9 proval problems which resulted in one or more of

10 the following actions: Withdrawal of approval or

11 temporary suspension of an approved applica12 tion under section 515 of the Federal Food,

13 Drug, and Cosmetic Act, mandatory product re14 call under section 518 of such Act, seizure under

15 section 304 of such Act, or criminal prosecution

16 under section 303 of such Act.

17 (K) Information for subparagraphs (A)

18 through (J) for fiscal year 1994.

19 (b) SECOND REPORT.—Within 120 days after the end

20 of each fiscal year during which such fees are collected, the

21 Secretary of Health and Human Services shall submit a

22 report on the implementation of the authority for such fees

23 during such fiscal year and on the use of the Food and Drug

24 Administration made of the fees collected during such fiscal

25 year.
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1 (c) ESCROW ACCOUNT REPORT.—The Secretary of

2 Health and Human Services shall report to the Congress

3 annually—

4 (1) the closing monthly balance of the escrow ac5 count established under section 742(g)(2) of the Fed6 eral Food, Drug, and Cosmetic Act,

7 (2) the monthly receipt of fees insuch account re8 ported for each fee established under section 742(b) of

9 such Act, and

10 (3) the monthly accrual of interest in such ac11 count

12 (d) COMMITTEES.—The reports described in sub13 sections (a), (b), and (c) shall be submitted to the Committee

14 on Energy and Commerce of the House of Representatives

15 and the Committee on Labor and Human Resources of the

16 Senate.

17 SEC. 5. REGULATIONS.

18 (a) GENERAL RULE.—This Act and the amendment

19 made by section 3 shall not be in effect after June 30, 1995,

20 unless the Secretary of Health and Human Services,

21 through the Commissioner of Food and Drugs, approves—

22 (1) regulations described in subsection (b), and

23 (2) regulations which identify devices in class II

24 of the device classes in section 513 of the Federal

25 Food, Drug, and Cosmetic Act that are appropriate
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1 for exemption from the requirement of section 510(k)

2 of such Act and which exempts such devices from such

3 requirement following their reclassification into class

4 I.

5 (b) REGULATIONS.—

6 (1) PROPOSED.—Not later than November 30,

7 1994, the Secretary shall issue proposed regulations

8 that—

9 (A) identify all devices in class I of the de10 vice classes in section 513 of the Federal Food,

11 Drug, and Cosmetic Act which are exempt from

12 the requirement of section 510(k) of such Act,

13 and

14 (B) identify the criteria for selecting devices

15 for such exemption.

16 The Secretary shall provide an opportunity to com17 ment on such proposed regulations for 60 days after

18 publication.

19 (2) FINAL.—Not later than February 28, 1995,

20 the Secretary shall issue final regulations which grant

21 an exemption to the devices identified in the proposed

22 regulations which clearly meet the criteria for exemp23 tion from the requirement of such section 510(k) of

24 the Federal Food, Drug, and Cosmetic Act.
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1 (3) OTHER REGULATIONS.— Not later than June

2 30, 1995, the Secretary shall issue final regulations

3 for the remainder of the devices from the list pub4 lished in the proposed regulations which exempts such

5 devices from such requirement or which continues the

6 applicability of such requirement.

7 (c) FEES.—An applicant under a device substantial

8 equivalence submission under section 510(k) of the Federal

9 Food, Drug, and Cosmetic Act which the Secretary proposed

10 to exempt from the requirement of such section under sub11 section (b)(1) shall not be required to pay a fee for such

12 submission unless the Secretary issues a final regulation re13 quiring such submission. An applicant under a substantial

14 equivalence submission under such section 510(k) which the

15 Secretary exempts from the requirement of such section

16 under subsection (a) shall not be required to pay a fee for

17 such submission.

18 SEC. 6. SUNSET.

19 This Act and the amendment made by section 3 shall

20 not be in effect after September 30, 1999.

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