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[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 1881 Enrolled Bill (ENR)]

        S.1881

                       One Hundred Eighth Congress

                                 of the

                        United States of America

                          AT THE SECOND SESSION

          Begun and held at the City of Washington on Tuesday,
           the twentieth day of January, two thousand and four

                                 An Act

 
  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)(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 (5)(B), in the first sentence, by striking 
        ``or poses'' and all that follows through the period and 
        inserting ``poses a threat to public health, fails to act in a 
        manner that is consistent with the purposes of this subsection, 
        or where the Secretary determines that there is a financial 
        conflict of interest in the relationship between the accredited 
        person and the owner or operator of a device establishment that 
        the accredited person has inspected under this subsection.'';
            (C) 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 ``accredited'' 
                and all that follows through the period and inserting 
                ``(accredited under paragraph (2) and identified under 
                clause (ii)(II)) as a person authorized to conduct such 
                inspections of device establishments.''; 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'';

                    (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

                    (III) in the fourth sentence, by striking ``granted 
                until'' and inserting ``granted or deemed to be granted 
                until''; 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'';

            (D) 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 other'' and inserting ``and with other''; and
                (ii) in the second sentence--

                    (I) by striking ``inspections'' and inserting 
                ``inspectional findings''; and
                    (II) by inserting ``relevant'' after ``together 
                with all other'';

            (E) in paragraph (6)(B)(iv)--
                (i) by inserting ``(I)'' after ``(iv)''; and
                (ii) by adding at the end the following:
    ``(II) If, during the two-year period following clearance under 
subparagraph (A), the Secretary determines that the device 
establishment is substantially not in compliance with this Act, the 
Secretary may, after notice and a written response, notify the 
establishment that the eligibility of the establishment for the 
inspections by accredited persons has been suspended.'';
            (F) 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'';
            (G) in paragraph (10)(B)(iii), by striking ``a reporting'' 
        and inserting ``a report''; and
            (H) 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.--
            (A) Prohibited acts.--Section 301(gg) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 331(gg)), as amended by 
        section 201(d) of Public Law 107-250 (116 Stat. 1609), is 
        amended to read as follows:
    ``(gg) The knowing failure to comply with paragraph (7)(E) of 
section 704(g); the knowing inclusion by a person accredited under 
paragraph (2) of such section of false information in an inspection 
report under paragraph (7)(A) of such section; or the knowing failure 
of such a person to include material facts in such a report.''.
            (B) Electronic labeling.--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--
                (i) 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'';
                (ii) by inserting a comma after ``means'';
                (iii) by striking ``requirements of law and, that'' and 
            inserting ``requirements of law, and that'';
                (iv) by striking ``the manufacturer affords health care 
            facilities the opportunity'' and inserting ``the 
            manufacturer affords such users the opportunity''; and
                (v) by striking ``the health care facility''.
    (c) Title III; Additional Amendments.--
        (1) Effective date.--Section 301(b) of Public Law 107-250 (116 
    Stat. 1616), is amended by striking ``18 months'' and inserting 
    ``36 months''.
        (2) Premarket notification.--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--
            (A) in paragraph (1)(B), by striking ``, adulterated'' and 
        inserting ``or adulterated''; and
            (B) in paragraph (2)--
                (i) in subparagraph (B), by striking ``, adulterated'' 
            and inserting ``or adulterated''; and
                (ii) 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''; and
            (C) in section 212(b)(2) (116 Stat. 1614), by striking ``, 
        such as phase IV trials,''.
SEC. 3. REPORT ON BARRIERS TO AVAILABILITY OF DEVICES INTENDED FOR 
CHILDREN.
    Not later than 180 days after the date of enactment of this Act, 
the Secretary of Health and Human Services shall submit to the 
Committee on Health, Education, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the House of Representatives a 
report on the barriers to the availability of devices intended for the 
treatment or diagnosis of diseases and conditions that affect children. 
The report shall include any recommendations of the Secretary of Health 
and Human Services for changes to existing statutory authority, 
regulations, or agency policy or practice to encourage the invention 
and development of such devices.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.
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