[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 1881 Introduced in Senate (IS)]







108th CONGRESS
  1st Session
                                S. 1881

  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.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           November 18, 2003

   Mr. Alexander (for himself, Mrs. Murray, Mr. Enzi, and Mr. Gregg) 
introduced the following bill; which was read twice and referred to the 
          Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
  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''.

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

    (a) Title I; Fees Relating to Medical Devices.--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--
            (1) in section 737--
                    (A) in paragraph (4)(B), by striking ``and for 
                which clinical data are generally necessary to provide 
                a reasonable assurance of safety and effectiveness'' 
                and inserting ``and for which substantial clinical data 
                are necessary to provide a reasonable assurance of 
                safety and effectiveness'';
                    (B) in paragraph (4)(D), by striking 
                ``manufacturing,'';
                    (C) in paragraph (5)(J), by striking ``a premarket 
                application'' and all that follows and inserting ``a 
                premarket application or premarket report under section 
                515 or a premarket application under section 351 of the 
                Public Health Service Act.''; and
                    (D) in paragraph (8), by striking ``The term 
                `affiliate' means a business entity that has a 
                relationship with a second business entity'' and 
                inserting ``The term `affiliate' means a business 
                entity that has a relationship with a second business 
                entity (whether domestic or international)''; and
            (2) in section 738--
                    (A) in subsection (a)(1)--
                            (i) in subparagraph (A)--
                                    (I) in the matter preceding clause 
                                (i) by striking ``subsection (d),'' and 
                                inserting ``subsections (d) and (e),'';
                                    (II) in clause (iv), by striking 
                                ``clause (i),'' and all that follows 
                                and inserting ``clause (i).''; and
                                    (III) in clause (vii), by striking 
                                ``clause (i),'' and all that follows 
                                and inserting ``clause (i), subject to 
                                any adjustment under subsection 
                                (e)(2)(C)(ii).''; and
                            (ii) in subparagraph (D), in each of 
                        clauses (i) and (ii), by striking 
                        ``application'' and inserting ``application, 
                        report,'';
                    (B) in subsection (d)(2)(B), beginning in the 
                second sentence, by striking ``firms. which show'' and 
                inserting ``firms, which show'';
                    (C) 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)--
                                    (I) in subparagraph (B), beginning 
                                in the second sentence, by striking 
                                ``firms. which show'' and inserting 
                                ``firms, which show''; and
                                    (II) in subparagraph (C)(i), by 
                                striking ``Where'' and inserting ``For 
                                fiscal year 2004 and each subsequent 
                                fiscal year, where'';
                    (D) in subsection (f), by striking ``for filing''; 
                and
                    (E) in subsection (h)(2)--
                            (i) by striking subparagraph (A)(ii) and 
                        inserting the following:
                            ``(ii) shall only be collected and 
                        available to defray increases in the costs of 
                        the resources allocated for the process 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 (the determination of the costs of the resources 
allocated for the process for the review of device applications for 
fiscal year 2003 through 2007, for purposes of this subparagraph, shall 
not include costs paid from fees collected under this section).''; and
                            (ii) in subparagraph (B)--
                                    (I) in clause (ii), by 
                                redesignating subclauses (I) and (II) 
                                as items (aa) and (bb), respectively;
                                    (II) by redesignating clauses (i) 
                                and (ii) as subclauses (I) and (II), 
                                respectively;
                                    (III) by striking ``The Secretary'' 
                                and inserting the following:
                            ``(i) In general.--The Secretary''; and
                                    (IV) by adding at the end the 
                                following:
                            ``(ii) More than 5 percent.--To the extent 
                        such costs are more than 5 percent below the 
                        specified level 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 ``conducting inspections of 
                establishments that manufacture, prepare, propagate, 
                compound, or process class II or class III devices, 
                which inspections are required under section 510(h) or 
                are inspections of such establishments required to 
                register under section 510(i).'';
                    (B) in paragraph (6)(A)--
                            (i) in clause (i), by striking ``of the 
                        establishment pursuant to subsection (h) or (i) 
                        of section 510'' and inserting ``described in 
                        paragraph (1)'';
                            (ii) in clause (ii)--
                                    (I) in the matter preceding 
                                subclause (I)--
                                            (aa) by striking ``each 
                                        inspection'' and inserting 
                                        ``inspections''; and
                                            (bb) by inserting ``during 
                                        a 2-year period'' after 
                                        ``person''; and
                                    (II) in subclause (I), by striking 
                                ``such a person'' and inserting ``an 
                                accredited person'';
                            (iii) in clause (iii)--
                                    (I) in the matter preceding 
                                subclause (I), by striking ``and the 
                                following additional conditions are 
                                met:'' and inserting ``and 1 or both of 
                                the following additional conditions are 
                                met:'';
                                    (II) in subclause (I), by striking 
                                ``under subclause (II) of this clause'' 
                                and inserting ``under clause 
                                (ii)(II)''; and
                                    (III) in subclause (II), by 
                                inserting ``or by a person accredited 
                                under paragraph (2)'' after ``by the 
                                Secretary'';
                            (iv) in clause (iv)(I)--
                                    (I) in the first sentence--
                                            (aa) by striking ``the two 
                                        immediately preceding 
                                        inspections of the 
                                        establishment'' and inserting 
                                        ``inspections of the 
                                        establishment during the 
                                        previous 4 years''; and
                                            (bb) by inserting 
                                        ``section'' after ``pursuant 
                                        to''; and
                                    (II) in the third sentence--
                                            (aa) by striking ``the 
                                        petition states a commercial 
                                        reason for the waiver;''; and
                                            (bb) by inserting ``not'' 
                                        after ``the Secretary has not 
                                        determined that the public 
                                        health would''; and
                            (v) in clause (iv)(II)--
                                    (I) by inserting ``of a device 
                                establishment required to register'' 
                                after ``to be conducted''; and
                                    (II) by inserting ``section'' after 
                                ``pursuant to'';
                    (C) in paragraph (6)(B)(iii)--
                            (i) in the first sentence, by striking ``, 
                        and data otherwise describing whether the 
                        establishment has consistently been in 
                        compliance with sections 501 and 502''; and
                            (ii) in the second sentence--
                                    (I) by striking ``inspections'' and 
                                inserting ``inspectional findings''; 
                                and
                                    (II) by striking ``, together with 
                                all other compliance data the Secretary 
                                deems necessary'';
                    (D) in paragraph (6)(C)(ii), by striking ``in 
                accordance with section 510(h), or has not during such 
                period been inspected pursuant to section 510(i), as 
                applicable'';
                    (E) in paragraph (10)(B)(iii), by striking ``a 
                reporting'' and inserting ``a report''; and
                    (F) in paragraph (12)--
                            (i) by striking subparagraph (A) and 
                        inserting the following:
                    ``(A) 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.--Section 502(f) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 352(f)), as amended by 
        section 206 of Public Law 107-250 (116 Stat. 1613), is amended, 
        in the last sentence--
                    (A) by inserting ``or by a health care professional 
                and required labeling for in vitro diagnostic devices 
                intended for use by health care professionals or in 
                blood establishments'' after ``in health care 
                facilities'';
                    (B) by inserting a comma after ``means'';
                    (C) by striking ``requirements of law and, that'' 
                and inserting ``requirements of law, and that'';
                    (D) by striking ``the manufacturer affords health 
                care facilities the opportunity'' and inserting ``the 
                manufacturer affords such users the opportunity''; and
                    (E) by striking ``the health care facility''.
    (c) Title III; Additional Amendments.--Section 510(o) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(o)), as added by 
section 302(b) of Public Law 107-250 (116 Stat. 1616), is amended--
            (1) in paragraph (1)(B), by striking ``, adulterated'' and 
        inserting ``or adulterated''; and
            (2) in paragraph (2)--
                    (A) in subparagraph (B), by striking ``, 
                adulterated'' and inserting ``or adulterated''; and
                    (B) in subparagraph (E), by striking 
                ``semicritical'' and inserting ``semi-critical''.
    (d) Miscellaneous Corrections.--
            (1) Certain amendments to section 515.--
                    (A) In general.--
                            (i) Technical correction.--Section 515(c) 
                        of the Federal Food, Drug, and Cosmetic Act (21 
                        U.S.C. 360e(c)), as amended by sections 209 and 
                        302(c)(2)(A) of Public Law 107-250 (116 Stat. 
                        1613, 1618), is amended by redesignating 
                        paragraph (3) (as added by section 209 of such 
                        Public Law) as paragraph (4).
                            (ii) Modular review.--Section 515(c)(4)(B) 
                        of the Federal Food, Drug, and Cosmetic Act (21 
                        U.S.C. 360e(c)(4)(B)) is amended by striking 
                        ``unless an issue of safety'' and inserting 
                        ``unless a significant issue of safety''.
                    (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 ``is amended in paragraph (3), as 
                redesignated by section 302(c)(2)(A) of this Act, by 
                adding''.
            (2) Certain amendments to section 738.--
                    (A) In general.--Section 738(a) of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 379j(a)), as 
                amended by subsection (a), is amended--
                            (i) in the matter preceding paragraph (1)--
                                    (I) by striking ``(a) Types of 
                                Fees.--Beginning on'' and inserting the 
                                following:
    ``(a) Types of Fees.--
            ``(1) In general.--Beginning on''; and
                                    (II) by striking ``this section as 
                                follows:'' and inserting ``this 
                                section.''; and
                            (ii) by striking ``(1) Premarket 
                        application,'' and inserting the following: 
                        ``(2) Premarket application,''.
                    (B) Conforming amendments.--Section 738 of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j), 
                as amended by subparagraph (A), is amended--
                            (i) in subsection (d)(1), in the last 
                        sentence, by striking ``subsection (a)(1)(A)'' 
                        and inserting ``subsection (a)(2)(A)'';
                            (ii) in subsection (e)(1), by striking 
                        ``subsection (a)(1)(A)(vii)'' and inserting 
                        ``subsection (a)(2)(A)(vii)'';
                            (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)(2)(A)(vii)''; and
                                    (II) in clause (ii), by striking 
                                ``subsection (a)(1)(A)(i)'' and 
                                inserting ``subsection (a)(2)(A)(i)''; 
                                and
                            (iv) in subsection (j), by striking 
                        ``subsection (a)(1)(D),'' and inserting 
                        ``subsection (a)(2)(D),''.
                    (C) 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)(2)(A)(ii)''.
            (3) Public law 107-250.--Public Law 107-250 is amended--
                    (A) in section 102(a) (116 Stat. 1589), by striking 
                ``(21 U.S.C. 379F et seq.)'' and inserting ``(21 U.S.C. 
                379f et seq.)'';
                    (B) in section 102(b) (116 Stat. 1600)--
                            (i) by striking paragraph (2);
                            (ii) in paragraph (1), by redesignating 
                        subparagraphs (A) and (B) as paragraphs (1) and 
                        (2), respectively; and
                            (iii) by striking:
    ``(b) Fee Exemption for Certain Entities Submitting Premarket 
Reports.--
            ``(1) In general.--A person submitting a premarket report'' 
        and inserting:
    ``(b) Fee Exemption for Certain Entities Submitting Premarket 
Reports.--A person submitting a premarket report'';
                    (C) in section 212(b)(2) (116 Stat. 1614), by 
                striking ``, such as phase IV trials,''; and
                    (D) in section 301(b) (116 Stat. 1616), by striking 
                ``18 months'' and inserting ``36 months''.

SEC. 3. HUMANITARIAN DEVICE EXEMPTION AND PEDIATRIC PRODUCTS.

    (a) Amendment to Federal Food, Drug, and Cosmetic Act.--Section 
520(m)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360j(m)(3)) is amended to read as follows:
    ``(3) Excluding devices intended for the treatment or diagnosis of 
diseases or conditions that affect pediatric patients, no person 
granted an exemption under paragraph (2) with respect to a device may 
sell the device for an amount that exceeds the costs of research and 
development, fabrication, and distribution of the device. The exclusion 
from the prohibition under the previous sentence for devices intended 
for the treatment or diagnosis of diseases or conditions that affect 
pediatric patients, shall not apply in the case of a request for an 
exemption under paragraph (2) made on or after October 1, 2007. In this 
paragraph, the term `pediatric patient' means a patient who is 14 years 
of age or younger at the time of diagnosis or treatment.''.
    (b) Report.--Not later than October 1, 2006, the Comptroller 
General of the United States, in consultation with the Secretary of 
Health and Human Services, shall submit to Congress a report that 
addresses the effectiveness of section 520(m) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360j(m)) in ensuring the development 
of devices designed to treat or diagnose diseases or conditions that 
affect fewer than 4,000 pediatric patients in the United States. Such 
report shall include the number and importance of devices for pediatric 
patients that are receiving exemptions under section 520(m) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)).
                                 <all>