H.R. 3493 (108^th): Medical Devices Technical Corrections Act

HR 3493 IH

To amend the Federal Food, Drug, and Cosmetic Act to make technical corrections relating to the amendments made by the Medical Device User Fee and Modernization Act of 2002, and for other purposes.

November 17, 2003

Mr. GREENWOOD (for himself and Ms. ESHOO) introduced the following bill; which was referred to the Committee on Energy and Commerce

To amend the Federal Food, Drug, and Cosmetic Act to make technical corrections relating to the amendments made by the Medical Device User Fee and Modernization Act of 2002, and for other purposes.

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

SECTION 1. SHORT TITLE.

This Act may be cited as the ‘Medical Devices Technical Corrections Act of 2003’.

SEC. 2. TECHNICAL CORRECTIONS REGARDING PUBLIC LAW 107-250.

(a) TITLE I; FEES RELATING TO MEDICAL DEVICES-

(1) TYPES OF FEES- Section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j), as added by section 102 of Public Law 107-250 (116 Stat. 1589), is amended by amending subsection (a) to read as follows:

‘(a) TYPES OF FEES- Beginning on the date of the enactment of the Medical Device User Fee and Modernization Act of 2002, the Secretary shall assess and collect fees in accordance with this section as follows:

‘(1) PREMARKET APPLICATION, PREMARKET REPORT, SUPPLEMENT, AND SUBMISSION FEE- Except as provided in paragraph (2) and subsections (d) and (e), each person who submits any of the following, on or after October 1, 2002, shall be subject to a fee established under subsection (c)(5) for the fiscal year involved in accordance with the following:

‘(A) A premarket application.

‘(B) For a premarket report, a fee equal to the fee that applies under subparagraph (A).

‘(C) For a panel track supplement, a fee equal to the fee that applies under subparagraph (A).

‘(D) For a 180-day supplement, a fee equal to 21.5 percent of the fee that applies under subparagraph (A).

‘(E) For a real-time supplement, a fee equal to 7.2 percent of the fee that applies under subparagraph (A).

‘(F) For an efficacy supplement, a fee equal to the fee that applies under subparagraph (A).

‘(G) For a premarket notification submission, a fee equal to 1.42 percent of the fee that applies under subparagraph (A), subject to any adjustment under subsection (e)(2)(C)(ii).

‘(2) EXCEPTIONS-

‘(A) HUMANITARIAN DEVICE EXEMPTION- An application under section 520(m) is not subject to any fee under paragraph (1).

‘(B) FURTHER MANUFACTURING USE- No fee shall be required under paragraph (1) for the submission of a premarket application under section 351 of the Public Health Service Act for a product licensed for further manufacturing use only.

‘(C) STATE OR FEDERAL GOVERNMENT SPONSORS- No fee shall be required under paragraph (1) for a premarket application, premarket report, supplement, or premarket notification submission submitted by a State or Federal Government entity unless the device involved is to be distributed commercially.

‘(D) PREMARKET NOTIFICATIONS BY THIRD PARTIES- No fee shall be required under paragraph (1) for a premarket notification submission reviewed by an accredited person pursuant to section 523.

‘(E) PEDIATRIC CONDITIONS OF USE-

‘(i) IN GENERAL- No fee shall be required under paragraph (1) for a premarket application, premarket report, or premarket notification submission if the proposed conditions of use for the device involved are solely for a pediatric population. No fee shall be required under such subparagraph for a supplement if the sole purpose of the supplement is to propose conditions of use for a pediatric population.

‘(ii) SUBSEQUENT PROPOSAL OF ADULT CONDITIONS OF USE- In the case of a person who submits a premarket application or premarket report for which, under clause (i), a fee under paragraph (1) is not required, any supplement to such application that proposes conditions of use for any adult population is subject to the fee that applies under such subparagraph for a premarket application.

‘(3) PAYMENT- The fee required by paragraph (1) shall be due upon submission of the premarket application, premarket report, supplement, or premarket notification submission, except that invoices for applications submitted on or after October 1, 2002, and before the date on which appropriations under subsection (h)(3) for fiscal year 2003 first become available shall be payable within 30 days of the issuance of such invoices. Applicants submitting portions of applications pursuant to section 515(c)(3) shall pay such fees upon submission of the first portion of such applications. The fees credited to fiscal year 2003 under this section shall

include all fees payable from October 1, 2002, through September 30, 2003.

‘(4) REFUNDS-

‘(A) APPLICATION REFUSED FOR FILING- The Secretary shall refund 75 percent of the fee paid under paragraph (1) for any application, report, or supplement that is refused for filing.

‘(B) APPLICATION WITHDRAWN BEFORE FILING- The Secretary shall refund 75 percent of the fee paid under paragraph (1) for any application, report, or supplement that is withdrawn prior to the filing decision of the Secretary.

‘(C) APPLICATION WITHDRAWN BEFORE FIRST ACTION- After receipt of a request for a refund of the fee paid under paragraph (1) for a premarket application, premarket report, or supplement that is withdrawn after filing but before a first action, the Secretary may return some or all of the fee. The amount of refund, if any, shall be based on the level of effort already expended on the review of such application, report, or supplement. The Secretary shall have sole discretion to refund a fee or portion of the fee under this subparagraph. A determination by the Secretary concerning a refund under this paragraph shall not be reviewable.’.

(2) OTHER CORRECTIONS RELATING TO FEES- Part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as added by section 102 of Public Law 107-250 (116 Stat. 1589), is amended--

(A) in section 737--

(i) in paragraph (4)--

(I) in subparagraph (B), by striking ‘and for which’ and all that follows and inserting the following: ‘and for which substantial clinical data are necessary to provide a reasonable assurance of safety and effectiveness.’; and

(II) in subparagraph (D), by striking ‘manufacturing,’;

(ii) in paragraph (5)(J), by striking ‘a premarket application’ and all that follows and inserting the following: ‘a premarket application or premarket report under section 515 or a premarket application under section 351 of the Public Health Service Act.’; and

(iii) in paragraph (8), in the matter preceding subparagraph (A), by inserting ‘(whether domestic or international)’ after ‘second business entity’; and

(B) in section 738--

(i) in subsection (d)(2)(B), beginning in the second sentence, by striking ‘firms. which show’ and inserting ‘firms, which show’;

(ii) in subsection (e)--

(I) in paragraph (1), by striking ‘Where’ and inserting ‘For fiscal year 2004 and each subsequent fiscal year, where’; and

(II) in paragraph (2)--

(aa) in subparagraph (B), beginning in the second sentence, by striking ‘firms. which show’ and inserting ‘firms, which show’; and

(bb) in subparagraph (C)(i), by striking ‘Where’ and inserting ‘For fiscal year 2004 and each subsequent fiscal year, where’;

(iii) in subsection (f), by striking ‘for filing’ and inserting ‘for review’; and

(iv) in subsection (h)(2)--

(I) in subparagraph (A), by striking clause (ii) and inserting the following:

‘(ii) shall only be collected and available to defray increases in the costs of the resources allocated for the purposes for the review of device applications (including increases in such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process) over such costs for fiscal year 2002 when multiplied by the adjustment factor.

For purposes of this subparagraph, the determination of the costs of the resources allocated for the process for the review of device applications for fiscal year 2003 through 2007 shall not include costs paid from fees collected under this section.’; and

(II) in subparagraph (B), by inserting after and below clause (ii)((II) the following:

‘To the extent such costs are more than 5 percent below the level specified in subparagraph (A)(ii), fees may not be collected under this section for that fiscal year.’.

(b) TITLE II; AMENDMENTS REGARDING REGULATION OF MEDICAL DEVICES-

(1) INSPECTIONS BY ACCREDITED PERSONS- Section 704(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(g)), as added by section 201 of Public Law 107-250 (116 Stat. 1602), is amended--

(A) in paragraph (1), in the first sentence, by striking ‘conducting inspections’ and all that follows and inserting the following: ‘conducting inspections of establishments that manufacture, prepare, propagate, compound, or process class II or class III devices, which inspections are required in section 510(h) or are inspections of such establishments required to register under section 510(i).’;

(B) in paragraph (6)(A)--

(i) in the matter preceding clause (i), by inserting ‘during a two-year period’ after ‘paragraph (2)’;

(ii) in clause (i), by striking ‘most recent inspection’ and all that follows through ‘section 510 as’ and inserting ‘most recent inspection described in paragraph (1) as’;

(iii) in clause (ii)--

(I) in the matter preceding subclause (I), by striking ‘With respect to’ and all that follows and inserting the following: ‘With respect to the inspections to be conducted by an accredited person during such two-year period--’;

(II) in subclause (I), by striking ‘such a person to conduct the inspection,’ and inserting ‘an accredited person to conduct the inspections,’; and

(III) in subclause (II), by striking ‘the inspection,’ and inserting ‘the inspections,’;

(iv) in clause (iii)--

(I) in the matter preceding subclause (I), by striking ‘United States,’ and all that follows and inserting ‘United States, and--’;

(II) in subclause (I)--

(aa) by striking ‘At least one’ and inserting ‘at least one’; and

(bb) by striking ‘identified under subclause (II) of this clause.’ and inserting ‘identified under clause (ii)(II); or’; and

(III) in subclause (II), by striking ‘The owner’ and inserting ‘the owner’; and

(v) in clause (iv)--

(I) in subclause (I), in the first sentence, by striking ‘In the case of’ and all that follows through ‘except that’ and inserting the following: ‘In the case of inspections to be conducted pursuant to section 510(h), persons accredited under paragraph (2) did not conduct any inspection of the establishment during the two preceding two-year periods referred to in such section with respect to the establishment, except that’;

(II) in subclause (II), by striking ‘In the case of’ and all that follows through ‘the Secretary’ and inserting the following: ‘In the case of inspections to be conducted of a device establishment required to register under section 510(i), the Secretary’;

(C) in paragraph (6)(B)--

(i) in clause (iii)--

(I) by striking ‘and data otherwise’ in the first sentence and all that follows through ‘reports of inspections regarding’ in the second sentence and inserting the following: ‘and data describing compliance with other applicable provisions of this Act. Such data shall include reports of inspectional findings regarding’; and

(II) in the second sentence, by striking ‘establishment, together with’ and all that follows and inserting ‘establishment.’; and

(ii) in clause (v), by adding at the end the following subclause:

‘(III) The agreement (or deemed agreement) of the Secretary under this subparagraph to the selection of an accredited person is effective for the two-year period referred to in the matter preceding clause (i) of subparagraph (A), subject to paragraph (5)(B).’;

(D) in paragraph (6)(C)(ii), in the last sentence, by inserting before the period the following: ‘and may submit a notice under subparagraph (A)’;

(E) in paragraph (10)(B)(iii), by striking ‘a reporting’ and inserting ‘a report’; and

(F) in paragraph (12)--

(i) in subparagraph (A), by striking ‘the number of’ the first place such term appears and all that follows and inserting the following: ‘the number of inspections conducted by accredited persons pursuant to this subsection and the number of inspections conducted by Federal employees pursuant to section 510(h) and of device establishments required to register under section 510(i);’; and

(ii) in subparagraph (E), by striking ‘obtained by the Secretary’ and all that follows and inserting ‘obtained by the Secretary pursuant to inspections conducted by Federal employees;’.

(2) OTHER CORRECTIONS- Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.), as amended by sections 204 and 206 of Public Law 107-250 (116 Stat. 1611, 1613), is amended--

(A) in section 502(f), in the last sentence--

(i) by striking ‘requirements of law and, that’ and inserting ‘requirements of law, that’; and

(ii) by striking ‘and after such request, promptly provides’ and inserting ‘and that, after receiving such request, the manufacturer promptly provides’; and

(B) in section 503(g)(4)(A), in the second sentence, by striking ‘shall, in determining whether’ and all that follows through ‘consult’ and inserting the following: ‘shall, in determining whether the product to be assigned is

appropriately classified as a combination product, consult’.

(c) TITLE III; ADDITIONAL AMENDMENTS-

(1) IN GENERAL- The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), as amended by sections 301 and 302 of Public Law 107-250 (116 Stat. 1616), is amended--

(A) in section 502 (21 U.S.C. 352)--

(i) by striking paragraph (u); and

(ii) by redesignating paragraph (v) as paragraph (u); and

(B) in section 510(o) (21 U.S.C. 360(o))--

(i) in paragraph (1)(B), in the third sentence, by striking ‘misbranded under section 502(o), adulterated under’ and inserting ‘misbranded under section 502(o) or adulterated under’; and

(ii) in paragraph (2)--

(I) in subparagraph (B), in the third sentence, by striking ‘misbranded under section 502(o), adulterated under’ and inserting ‘misbranded under section 502(o) or adulterated under’; and

(II) in subparagraph (E), by striking ‘semicritical’ and inserting ‘semi-critical’.

(2) CONFORMING AMENDMENT- Section 301 of Public Law 107-250 (116 Stat. 1616) is amended by striking subsection (b).

(d) MISCELLANEOUS CORRECTIONS-

(1) CERTAIN AMENDMENTS REGARDING SECTION 515(c)-

(A) IN GENERAL- Section 515(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e), as amended by sections 209 and 302(c)(2)(A) of Public Law 107-250 (116 Stat. 1613, 1618), is amended--

(i) by redesignating the second paragraph (3) (added by section 209 of such Public Law) as paragraph (4); and

(ii) in paragraph (4) (as so redesignated), in subparagraph (B), by striking ‘an issue’ and inserting ‘a new issue’.

(B) CONFORMING AMENDMENT- Section 210 of Public Law 107-250 (116 Stat. 1614) is amended by striking ‘, as amended’ and all that follows through ‘by adding’ and inserting the following: ‘is amended in paragraph (3), as redesignated by section 302(c)(2)(A) of this Act, by adding’.

(2) CONFORMING AMENDMENTS REGARDING REFERENCES TO SECTION 738(a)-

(A) IN GENERAL- Section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j), as amended by subparagraph (A) of this paragraph, is amended--

(i) in subsection (d)(1), in the last sentence, by striking ‘clauses (i) through (vi) of subsection (a)(1)(A)’ and inserting ‘subparagraphs (A) through (F) of subsection (a)(1)’;

(ii) in subsection (e)(1), by striking ‘subsection (a)(1)(A)(vii)’ and inserting ‘subsection (a)(1)(G)’;

(iii) in subsection (e)(2)(C)--

(I) in each of clauses (i) and (ii), by striking ‘subsection (a)(1)(A)(vii)’ and inserting ‘subsection (a)(1)(G)’; and

(II) in clause (ii), by striking ‘subsection (a)(1)(A)(i)’ and inserting ‘subsection (a)(1)(A)’; and

(iv) in subsection (j), by striking ‘subsection (a)(1)(D),’ and inserting ‘subsection (a)(4),’.

(B) ADDITIONAL CONFORMING AMENDMENT- Section 102(b)(1) of Public Law 107-250 (116 Stat. 1600) is amended in the matter preceding subparagraph (A) by striking ‘section 738(a)(1)(A)(ii)’ and inserting ‘section 738(a)(1)(B)’.

(3) PUBLIC LAW 107-250- Public Law 107-250 is amended--

(A) in section 102--

(i) in subsection (a) (116 Stat. 1589), by striking ‘(21 U.S.C. 379F et seq.)’ and inserting ‘(21 U.S.C. 379f et seq.)’; and

(ii) in subsection (b) (116 Stat. 1600), by striking paragraph (2);

(B) in section 212(b)(2) (116 Stat. 1614), by striking ‘medical devices, such as phase IV trials, and’ and inserting ‘medical devices and’; and

(C) in section 214(a)(3) (116 Stat. 1615), by striking ‘discussion’ and inserting ‘presentation’.

(4) PUBLIC HEALTH SERVICE ACT- Section 498C of the Public Health Service Act (42 U.S.C. 289g-3), as added by section 215(b) of Public Law 107-250 (116 Stat. 1615), is amended in subsection (a) by striking ‘Director of NIH may’ and inserting ‘Director of NIH shall’.

(e) HUMANITARIAN DEVICE EXEMPTION; PEDIATRIC PATIENTS- Section 520(m)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(3)) is amended--

(1) by striking ‘(3) No person’ and inserting ‘(3)(A) Except as provided in subparagraph (B), no person’; and

(2) by adding at the end the following:

‘(B)(i) Subparagraph (A) does not apply with respect to any device intended for the treatment or diagnosis of a pediatric condition.

‘(ii) For purposes of this subsection:

‘(I) The term ‘pediatric condition’ means a disease, disorder, or other condition unique to, more serious, or more prevalent in pediatric patients.

‘(II) The term ‘pediatric patient’ means a patient who is under 15 years of age at the time of diagnosis or treatment.’.

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