[Congressional Record (Bound Edition), Volume 150 (2004), Part 4]
[Senate]
[Pages 4362-4364]
[From the U.S. Government Publishing Office, www.gpo.gov]




               MEDICAL DEVICES TECHNICAL CORRECTIONS ACT

  Mr. FRIST. Mr. President, I ask unanimous consent that the Chair lay 
before the Senate a message from the House of Representatives on (S. 
1881) to amend the Federal Food, Drug, and Cosmetic Act to make 
technical corrections relating to the amendments by the Medical Device 
User Fee and Modernization Act of 2002, and for other purposes.
  The PRESIDING OFFICER laid before the Senate the following message 
from the House of Representatives:

       Resolved, That the bill from the Senate (S. 1881) entitled 
     ``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'', do pass with the following 
     amendment:
       Strike out all after the enacting clause and insert:

     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

[[Page 4363]]

       (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

[[Page 4364]]

       (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.

  Mr. FRIST. I ask unanimous consent that the Senate concur in the 
House amendment, the motion to reconsider be laid upon the table, and 
any statements relating to the bill be printed in the Record.
  The PRESIDING OFFICER. Without objection, it is so ordered.

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