[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 1881 Reported in House (RH)]

                                                 Union Calendar No. 250
108th CONGRESS
  2d Session
                                S. 1881

                          [Report No. 108-433]


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            December 8, 2003

            Referred to the Committee on Energy and Commerce

                             March 9, 2004

  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 Senate passed bill, see copy of bill as referred in the 
             House of Representatives on December 8, 2003]

_______________________________________________________________________

                                 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.




                                                 Union Calendar No. 250

108th CONGRESS

  2d Session

                                S. 1881

                          [Report No. 108-433]

_______________________________________________________________________

                                 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.

_______________________________________________________________________

                             March 9, 2004

  Reported with an amendment, committed to the Committee of the Whole 
       House on the State of the Union, and ordered to be printed