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[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3493 Referred in Senate (RFS)]

  2d Session
                                H. R. 3493

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                            January 28, 2004

     Received; read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 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 
                inserting after ``standards of accreditation,'' the 
                following: ``or where the Secretary has information 
                indicating that the relationship between the 
                establishment and the accredited person may create a 
                conflict of interest,'';
                    (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 
                                ``identified under subclause (II) of 
                                this clause'' and inserting 
                                ``identified under clause (ii)(II) as a 
                                person authorized to conduct 
                                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'';
                            (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''; and
                            (vi) by adding at the end the following 
                        clause:
            ``(v) The eligibility of the establishment for inspections 
        by accredited persons has not been suspended under subparagraph 
        (B)(iv)(II).'';
                    (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'';
                            (ii) in the second sentence--
                                    (I) by striking ``inspections'' and 
                                inserting ``inspectional findings''; 
                                and
                                    (II) by inserting ``relevant'' 
                                after ``together with all other''; and
                            (iii)(I) by inserting ``(I)'' after 
                        ``(iii)'';
                            (II) by adding at the end the following 
                        subclause:
    ``(II) In making a decision under this paragraph, the Secretary may 
consider any information relevant to the establishment's compliance 
with any provision of this Act. Nothing in the preceding sentence shall 
be construed to expand the Secretary's inspectional authority under 
subsection (a).'';
                    (E) in paragraph (6)(B)(iv)--
                            (i) by inserting ``(I)'' after ``(iv)''; 
                        and
                            (ii) by adding at the end the following 
                        subclause:
    ``(II) If, during the two-year period following clearance under 
subparagraph (A) with respect to a device establishment, the Secretary 
obtains information indicating significant deviations from compliance 
with this Act or implementing regulations, the Secretary may, after 
notice and an opportunity for a written response, notify the 
establishment that the eligibility of the establishment for inspections 
by accredited person 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.

            Passed the House of Representatives January 27, 2004.

            Attest:

                                                 JEFF TRANDAHL,

                                                                 Clerk.
```