Report text available as:

  • TXT
  • PDF   (PDF provides a complete and accurate display of this text.) Tip ?

108th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES
 2d Session                                                     108-433

======================================================================



 
               MEDICAL DEVICES TECHNICAL CORRECTIONS ACT

                                _______
                                

 March 9, 2004.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

    Mr. Barton of Texas, from the Committee on Energy and Commerce, 
                        submitted the following

                              R E P O R T

                         [To accompany S. 1881]

      [Including cost estimate of the Congressional Budget Office]

  The Committee on Energy and Commerce, to whom was referred 
the bill (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, having 
considered the same, report favorably thereon with an amendment 
and recommend that the bill as amended do pass.

                                CONTENTS

                                                                   Page
Amendment........................................................     1
Purpose and Summary..............................................     5
Background and Need for Legislation..............................     5
Hearings.........................................................     5
Committee Consideration..........................................     5
Committee Votes..................................................     6
Committee Oversight Findings.....................................     6
Statement of General Performance Goals and Objectives............     6
New Budget Authority, Entitlement Authority, and Tax Expenditures     6
Committee Cost Estimate..........................................     6
Congressional Budget Office Estimate.............................     6
Federal Mandates Statement.......................................     7
Advisory Committee Statement.....................................     7
Constitutional Authority Statement...............................     7
Applicability to Legislative Branch..............................     7
Section-by-Section Analysis of the Legislation...................     7
Changes in Existing Law Made by the Bill, as Reported............     8

  The amendment is as follows:
  Strike all after the enacting clause and insert the 
following:

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.

                          Purpose and Summary

    S. 1881 makes technical and conforming changes to the 
Medical Device User Fee and Modernization Act of 2002.

                  Background and Need for Legislation

    On October 26, 2002, President Bush signed into law the 
Medical Device User Fee and Modernization Act of 2002 (P.L. 
107-250). This legislation provided increased resources to the 
Food and Drug Administration (FDA) through user fees and made 
other significant reforms to the FDA in order to improve the 
quality and speed of medical device approvals, but is in need 
of technical corrections.

                                Hearings

    The Committee on Energy and Commerce has not held hearings 
on the legislation.

                        Committee Consideration

    On March 3, 2004, the Full Committee met in open markup 
session and favorably ordered S. 1881 reported to the House, as 
amended, by a voice vote, a quorum being present.

                            Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list the record votes 
on the motion to report legislation and amendments thereto. 
There were no record votes taken in connection with ordering S. 
1881 reported. A motion by Mr. Barton to order S. 1881 reported 
to the House, as amended, was agreed to by a voice vote.

                      Committee Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee has not held oversight 
or legislative hearings on this legislation.

         Statement of General Performance Goals and Objectives

    The goal of S. 1881 is to make technical and conforming 
changes to the Medical Device User Fee and Modernization Act of 
2002.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    In compliance with clause 3(c)(2) of rule XIII of the Rules 
of the House of Representatives, the Committee finds that S. 
1881, the Medical Device Technical Corrections Act, would 
result in no new or increased budget authority, entitlement 
authority, or tax expenditures or revenues.

                        Committee Cost Estimate

    The Committee adopts as its own the cost estimate prepared 
by the Director of the Congressional Budget Office pursuant to 
section 402 of the Congressional Budget Act of 1974.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII of the Rules of the 
House of Representatives, the following is the cost estimate 
provided by the Congressional Budget Office pursuant to section 
402 of the Congressional Budget Act of 1974:

                                     U.S. Congress,
                               Congressional Budget Office,
                                     Washington, DC, March 8, 2004.
Hon. Joe Barton,
Chairman, Committee on Energy and Commerce, House of Representatives, 
        Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for S. 1881, the Medical 
Devices Technical Corrections Act.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Julia 
Christensen.
            Sincerely,
                                       Douglas Holtz-Eakin,
                                                          Director.
    Enclosure.

S. 1881--Medical Devices Technical Corrections Act

    S. 1881 would make technical changes regarding the Medical 
Device User Fee and Modernization Act of 2002 (Public Law 107-
250). CBO estimates that enacting S. 1881 would have a 
negligible impact on the Federal budget and have no effect on 
direct spending or receipts.
    The act would clarify the existing statute underlying the 
Food and Drug Administration's (FDA's) user fee program for 
medical devices. We anticipate that those modifications would 
not significantly change the costs for FDA to administer the 
program, nor would it affect user fee collections. S. 1881 also 
would require the Secretary of Health and Human Services to 
conduct a study on the availability of medical devices for 
children. Assuming the availability of appropriated funds, CBO 
estimates that implementing S. 1881 would cost less than 
$500,000 a year.
    This legislation contains no intergovernmental or private-
sector mandates as defined in the Unfunded Mandates Reform Act 
and would impose no costs on State, local, or tribal 
governments.
    The CBO staff contact for this estimate is Julia 
Christensen. This estimate was approved by Peter H. Fontaine, 
Deputy Assistant Director for Budget Analysis.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                   Constitutional Authority Statement

    Pursuant to clause 3(d)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee finds that the 
Constitutional authority for this legislation is provided in 
Article I, section 8, clause 3, which grants Congress the power 
to regulate commerce with foreign nations, among the several 
States, and with the Indian tribes.

                  Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

             Section-by-Section Analysis of the Legislation


Section 1. Short title

    Section 1 designates the short title as the ``Medical 
Device Technical Corrections Act.''

Section 2. Technical amendments regarding Public Law 107-250

    Section 2 makes several technical changes to the Medical 
Device User Fee and Modernization Act of 2002 (P.L. 107-250). 
It renumbers and conforms the appropriate sections of the 
Federal Food, Drug, and Cosmetic Act, making grammatical 
corrections, inserting periods, and correcting comma placement.
    Section 2 clarifies the distinction between a ``panel track 
supplement'' for which substantial clinical data is required to 
demonstrate a reasonable assurance of safety and effectiveness 
and a ``180-day supplement'' for which such data is not 
required. Next, section 2 clarifies that premarket reports are 
within the definition of ``process for the review of device 
applications.'' Further, section 2 clarifies the term 
``affiliate'' to include international as well as domestic 
affiliates in the user fee program.
    Section 2 makes technical changes clarifying that the third 
party inspection program applies to 510(h) inspections of 
establishments and inspections of foreign facilities required 
to register with the Food and Drug Administration (FDA). 
Section 2 ensures that facilities can work with third party 
inspectors to allow them to complete a full 510(h) inspection 
over the course of a two year period. Section 2 clarifies the 
law and allows entities to certify that a foreign country 
recognizes the third party conducting the inspection, instead 
of requiring a statement that such a country recognizes FDA's 
inspectional authority. Section 2 also ensures that companies 
can use third party inspectors for two consecutive 510(h) 
inspections before requesting special permission from the 
Secretary for the third such inspection. Finally, section 2 
makes important modifications to section 301 by providing an 
18-month implementation delay for all branding requirements and 
clarifies the definition of modular review to be consistent 
with the FDA's modular review program.

Section 3. Report on barriers to availability of devices intended for 
        children

    Section 3 requests that the FDA complete a report on the 
barriers to the availability of devices intended for pediatric 
patients, and provide policy recommendations as to what could 
be changed in existing law to address this issue.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italics, existing law in which no change 
is proposed is shown in roman):

FEDERAL FOOD, DRUG, AND COSMETIC ACT

           *       *       *       *       *       *       *



               CHAPTER III--PROHIBITED ACTS AND PENALTIES


                            PROHIBITED ACTS

  Sec. 301. The following acts and the causing thereof are 
hereby prohibited:
  (a) * * *

           *       *       *       *       *       *       *

  [(gg) The knowing failure of a person accredited under 
paragraph (2) of section 704(g) to comply with paragraph (7)(E) 
of such section; the knowing inclusion by such a person 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.]
  (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.

           *       *       *       *       *       *       *


                      CHAPTER V--DRUGS AND DEVICES

                    Subchapter A--Drugs and Devices

  Sec. 501. * * *

           *       *       *       *       *       *       *


                      MISBRANDED DRUGS AND DEVICES

  Sec. 502. A drug or device shall be deemed to be misbranded--
  (a) * * *

           *       *       *       *       *       *       *

  (f) Unless its labeling bears (1) adequate directions for 
use; and (2) such adequate warnings against use in those 
pathological conditions or by children where its use may be 
dangerous to health, or against unsafe dosage or methods or 
duration of administration or application, in such manner and 
form, as are necessary for the protection of users, except that 
where any requirement of clause (1) of this paragraph, as 
applied to any drug or device, is not necessary for the 
protection of the public health, the Secretary shall promulgate 
regulations exempting such drug or device from such 
requirement. Required labeling for prescription devices 
intended for use in health care facilities 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 may be made available solely by electronic 
means, provided that the labeling complies with all applicable 
[requirements of law and, that] requirements of law, and that 
[the manufacturer affords health care facilities the 
opportunity] the manufacturer affords such users the 
opportunity to request the labeling in paper form, and after 
such request, promptly provides [the health care facility] the 
requested information without additional cost.

           *       *       *       *       *       *       *


            REGISTRATION OF PRODUCERS OF DRUGS AND DEVICES 

  Sec. 510. (a) As used in this section--
          (1) * * *

           *       *       *       *       *       *       *

  (o)(1) With respect to reprocessed single-use devices for 
which reports are required under subsection (k):
          (A) * * *
          (B) In the case of each report under subsection (k) 
        that was submitted to the Secretary before the 
        publication of the initial list under subparagraph (A), 
        or any revision thereof, and was for a device or type 
        of device included on such list, the person who 
        submitted the report under subsection (k) shall submit 
        validation data as described in subparagraph (A) to the 
        Secretary not later than nine months after the 
        publication of the list. During such nine-month period, 
        the Secretary may not take any action under this Act 
        against such device solely on the basis that the 
        validation data for the device have not been submitted 
        to the Secretary. After the submission of the 
        validation data to the Secretary, the Secretary may not 
        determine that the device is misbranded under section 
        502(o)[, adulterated] or adulterated under section 
        501(f)(1)(B), or take action against the device under 
        section 301(p) for failure to provide any information 
        required by subsection (k) until (i) the review is 
        terminated by withdrawal of the submission of the 
        report under subsection (k); (ii) the Secretary finds 
        the data to be acceptable and issues a letter; or (iii) 
        the Secretary determines that the device is not 
        substantially equivalent to a predicate device. Upon a 
        determination that a device is not substantially 
        equivalent to a predicate device, or if such submission 
        is withdrawn, the device can no longer be legally 
        marketed.

           *       *       *       *       *       *       *

  (2) With respect to critical or semi-critical reprocessed 
single-use devices that, under subsection (l) or (m), are 
exempt from the requirement of submitting reports under 
subsection (k):
          (A) * * *
          (B) For each device or type of device included on the 
        list under subparagraph (A), a report under subsection 
        (k) shall be submitted to the Secretary not later than 
        15 months after the publication of the initial list, or 
        a revision of the list, whichever terminates the 
        exemption for the device. During such 15-month period, 
        the Secretary may not take any action under this Act 
        against such device solely on the basis that such 
        report has not been submitted to the Secretary. After 
        the submission of the report to the Secretary the 
        Secretary may not determine that the device is 
        misbranded under section 502(o)[, adulterated] or 
        adulterated under section 501(f)(1)(B), or take action 
        against the device under section 301(p) for failure to 
        provide any information required by subsection (k) 
        until (i) the review is terminated by withdrawal of the 
        submission; (ii) the Secretary determines by order that 
        the device is substantially equivalent to a predicate 
        device; or (iii) the Secretary determines by order that 
        the device is not substantially equivalent to a 
        predicate device. Upon a determination that a device is 
        not substantially equivalent to a predicate device, the 
        device can no longer be legally marketed.

           *       *       *       *       *       *       *

          (E) The termination under subparagraph (A) of an 
        exemption under subsection (l) or (m) for a critical or 
        [semicritical] semi-critical reprocessed single-use 
        device does not terminate the exemption under 
        subsection (l) or (m) for the original device.

           *       *       *       *       *       *       *


                           PREMARKET APPROVAL

                          General Requirement

  Sec. 515. (a) * * *

           *       *       *       *       *       *       *


                   Application for Premarket Approval

  (c)(1) * * *

           *       *       *       *       *       *       *

  [(3)] (4)(A) Prior to the submission of an application under 
this subsection, the Secretary shall accept and review any 
portion of the application that the applicant and the Secretary 
agree is complete, ready, and appropriate for review, except 
that such requirement does not apply, and the Secretary has 
discretion whether to accept and review such portion, during 
any period in which, under section 738(g), the Secretary does 
not have the authority to collect fees under section 738(a).
  (B) Each portion of a submission reviewed under subparagraph 
(A) and found acceptable by the Secretary shall not be further 
reviewed after receipt of an application that satisfies the 
requirements of paragraph (1), [unless an issue of safety] 
unless a significant issue of safety or effectiveness provides 
the Secretary reason to review such accepted portion.
  (C) Whenever the Secretary determines that a portion of a 
submission under subparagraph (A) is unacceptable, the 
Secretary shall, in writing, provide to the applicant a 
description of any deficiencies in such portion and identify 
the information that is required to correct these deficiencies, 
unless the applicant is no longer pursuing the application.''.

           *       *       *       *       *       *       *


                     CHAPTER VII--GENERAL AUTHORITY

Subchapter A--General Administrative Provisions

           *       *       *       *       *       *       *


                           FACTORY INSPECTION

  Sec. 704. (a)(1) * * *

           *       *       *       *       *       *       *

  (g)(1) Not later than one year after the date of the 
enactment of this subsection, the Secretary shall, subject to 
the provisions of this subsection, accredit persons for the 
purpose of [conducting inspections of establishments that 
manufacture, prepare, propagate, compound, or process class II 
or class III devices that are required in section 510(h), or 
inspections of such establishments required to register 
pursuant to section 510(i).] 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). The 
owner or operator of such an establishment that is eligible 
under paragraph (6) may, from the list published under 
paragraph (4), select an accredited person to conduct such 
inspections.

           *       *       *       *       *       *       *

  (5)(A) * * *
  (B) The Secretary may withdraw accreditation of any person 
accredited under paragraph (2), after providing notice and an 
opportunity for an informal hearing, when such person is 
substantially not in compliance with the standards of 
accreditation, [or poses a threat to public health or fails to 
act in a manner that is consistent with the purposes of this 
subsection.] 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. The 
Secretary may suspend the accreditation of such person during 
the pendency of the process under the preceding sentence.
  (6)(A) Subject to subparagraphs (B) and (C), a device 
establishment is eligible for inspections by persons accredited 
under paragraph (2) if the following conditions are met:
          (i) The Secretary classified the results of the most 
        recent inspection [of the establishment pursuant to 
        subsection (h) or (i) of section 510] described in 
        paragraph (1) as ``no action indicated'' or ``voluntary 
        action indicated''.
          (ii) With respect to [each inspection] inspections to 
        be conducted by an accredited person during a 2-year 
        period--
                  (I) the owner or operator of the 
                establishment submits to the Secretary a notice 
                requesting clearance to use [such a person] an 
                accredited person to conduct the inspection, 
                and the Secretary provides such clearance; and

           *       *       *       *       *       *       *

          (iii) With respect to the devices that are 
        manufactured, prepared, propagated, compounded, or 
        processed by the establishment, at least one of such 
        devices is marketed in the United States, [and the 
        following additional conditions are met:] and 1 or both 
        of the following additional conditions are met:
                  (I) At least one of such devices is marketed, 
                or is intended to be marketed, in one or more 
                foreign countries, one of which countries 
                certifies, accredits, or otherwise recognizes 
                the person [accredited under paragraph (2) and 
                identified under subclause (II) of this 
                clause.] (accredited under paragraph (2) and 
                identified under clause (ii)(II)) as a person 
                authorized to conduct such inspections of 
                device establishments.
                  (II) The owner or operator of the 
                establishment submits to the Secretary a 
                statement that the law of a country in which 
                such a device is marketed, or is intended to be 
                marketed, recognizes an inspection of the 
                establishment by the Secretary or by a person 
                accredited under paragraph (2), and not later 
                than 30 days after receiving such statement, 
                the Secretary informs the owner or operator of 
                the establishment that the owner or operator 
                may submit a notice requesting clearance under 
                clause (ii).
          (iv)(I) In the case of an inspection to be conducted 
        pursuant to section 510(h), persons accredited under 
        paragraph (2) did not conduct [the two immediately 
        preceding inspections of the establishment] inspections 
        of the establishment during the previous 4 years, 
        except that the establishment may petition the 
        Secretary for a waiver of such condition. Such a waiver 
        may be granted only if the petition states a commercial 
        reason for the waiver; the Secretary determines that 
        the public health would be served by granting the 
        waiver; and the Secretary has conducted an inspection 
        of the establishment during the four-year period 
        preceding the date on which the notice under clause 
        (ii) is submitted to the Secretary. Such a waiver is 
        deemed to be granted only if [the petition states a 
        commercial reason for the waiver;] the Secretary has 
        not determined that the public health would not be 
        served by granting the waiver; and the owner or 
        operator of the device establishment has requested in 
        writing, not later than 18 months following the most 
        recent inspection of such establishment by a person 
        accredited under paragraph (2), that the Secretary 
        inspect the establishment and the Secretary has not 
        conducted an inspection within 30 months after the most 
        recent inspection. With respect to such a waiver that 
        is granted or deemed to be granted, no additional such 
        waiver may be [granted until] granted or deemed to be 
        granted until after the Secretary has conducted an 
        inspection of the establishment.
          (II) In the case of an inspection to be conducted of 
        a device establishment required to register pursuant to 
        section 510(i), the Secretary periodically conducts 
        inspections of the establishment.

           *       *       *       *       *       *       *

  (B)(i) * * *

           *       *       *       *       *       *       *

  (iii) The compliance data to be submitted by a device 
establishment under clause (ii) are data describing whether the 
quality controls of the establishment have been sufficient for 
ensuring consistent compliance with current good manufacturing 
practice within the meaning of section 501(h)[, and data 
otherwise describing whether the establishment has consistently 
been in compliance with sections 501 and 502 and other] and 
with other applicable provisions of this Act. Such data shall 
include complete reports of [inspections] inspectional findings 
regarding good manufacturing practice or other quality control 
audits that, during the preceding two-year period, were 
conducted at the establishment by persons other than the owner 
or operator of the establishment, together with all other 
relevant compliance data the Secretary deems necessary. Data 
under the preceding sentence shall demonstrate to the Secretary 
whether the establishment has facilitated consistent compliance 
by promptly correcting any compliance problems identified in 
such inspections.
  (iv)(I) Not later than 60 days after receiving compliance 
data under clause (iii) from a device establishment, the 
Secretary shall provide or deny clearance under subparagraph 
(A). The Secretary may deny clearance if the Secretary 
determines that the establishment has failed to demonstrate 
consistent compliance for purposes of clause (iii). The 
Secretary shall provide to the establishment a statement of 
such reasons for such determination. If the Secretary fails to 
provide such statement to the establishment within such 60-day 
period, the establishment is deemed to have such clearance.
  (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.

           *       *       *       *       *       *       *

  (C)(i) * * *
  (ii) If the Secretary denies a petition under clause (i), the 
device establishment involved may, after the expiration of one 
year after such denial, again petition the Secretary for a 
determination of eligibility for inspection by persons 
accredited by the Secretary under paragraph (2). If the 
Secretary denies such petition, the Secretary shall provide the 
establishment with such reasons for such denial within 60 days 
after the denial. If, as of the expiration of 48 months after 
the receipt of the first petition, the establishment has not 
been inspected by the Secretary [in accordance with section 
510(h), or has not during such period been inspected pursuant 
to section 510(i), as applicable], the establishment is 
eligible for further inspections by accredited persons.

           *       *       *       *       *       *       *

  (10)(A) * * *
  (B)(i) * * *

           *       *       *       *       *       *       *

  (iii) Not later than March 31, 2003, the Comptroller General 
shall complete the determinations required in this subparagraph 
and submit to the Secretary and the Congress [a reporting] a 
report describing the findings made through such 
determinations.

           *       *       *       *       *       *       *

  (12) No later than four years after the enactment of this 
subsection the Comptroller General shall report to the 
Committee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Education, Labor 
and Pensions of the Senate--
          [(A) the number of inspections pursuant to 
        subsections (h) and (i) of section 510 conducted by 
        accredited persons and the number of inspections 
        pursuant to such subsections conducted by Federal 
        employees;]
          (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);

           *       *       *       *       *       *       *

          (E) whether this subsection is achieving the goal of 
        ensuring more information about device establishment 
        compliance is being presented to the Secretary, and 
        whether that information is of a quality consistent 
        with information [obtained by the Secretary pursuant to 
        subsection (h) or (i) of section 510;] obtained by the 
        Secretary pursuant to inspections conducted by Federal 
        employees;

           *       *       *       *       *       *       *


Subchapter C--Fees

           *       *       *       *       *       *       *


                    PART 3--FEES RELATING TO DEVICES

SEC. 737. DEFINITIONS.

  For purposes of this subchapter:
          (1) * * *

           *       *       *       *       *       *       *

          (4)(A) * * *
          (B) The term ``panel-track supplement'' means a 
        supplement to an approved premarket application or 
        premarket report under section 515 that requests a 
        significant change in design or performance of the 
        device, or a new indication for use of the device, [and 
        for which clinical data are generally necessary to 
        provide a reasonable assurance of safety and 
        effectiveness] and for which substantial clinical data 
        are necessary to provide a reasonable assurance of 
        safety and effectiveness.

           *       *       *       *       *       *       *

          (D) The term ``real-time supplement'' means a 
        supplement to an approved premarket application or 
        premarket report under section 515 that requests a 
        minor change to the device, such as a minor change to 
        the design of the device, software, [manufacturing,] 
        sterilization, or labeling, and for which the applicant 
        has requested and the agency has granted a meeting or 
        similar forum to jointly review and determine the 
        status of the supplement.

           *       *       *       *       *       *       *

          (5) The term ``process for the review of device 
        applications'' means the following activities of the 
        Secretary with respect to the review of premarket 
        applications, premarket reports, supplements, and 
        premarket notification submissions:
                  (A) * * *

           *       *       *       *       *       *       *

                  (J) Evaluation of postmarket studies required 
                as a condition of an approval of [a premarket 
                application under section 515 or section 351 of 
                the Public Health Service Act.] a premarket 
                application or premarket report under section 
                515 or a premarket application under section 
                351 of the Public Health Service Act.

           *       *       *       *       *       *       *

          (8) [The term ``affiliate'' means a business entity 
        that has a relationship with a second business entity] 
        The term `affiliate' means a business entity that has a 
        relationship with a second business entity (whether 
        domestic or international) if, directly or indirectly--
                  (A) * * *

           *       *       *       *       *       *       *


SEC. 738. AUTHORITY TO ASSESS AND USE DEVICE FEES.

  [(a) Types of Fees.--Beginning on] (a) Types of Fees.--
          (1) In general.--Beginning on the date of the 
        enactment of the Medical Device User Fee and 
        Modernization Act of 2002, the Secretary shall assess 
        and collect fees in accordance with [this section as 
        follows:] this section.
          [(1) Premarket application,] (2) Premarket 
        application, premarket report, supplement, and 
        submission fee.--
                  (A) In general.--Except as provided in 
                subparagraph (B) and [subsection (d),] 
                subsections (d) and (e), each person who 
                submits any of the following, on or after 
                October 1, 2002, shall be subject to a fee 
                established under subsection (c)(5) for the 
                fiscal year involved in accordance with the 
                following:
                          (i) * * *

           *       *       *       *       *       *       *

                          (iv) For a 180-day supplement, a fee 
                        equal to 21.5 percent of the fee that 
                        applies under [clause (i), subject to 
                        any adjustment under subsection 
                        (c)(3).] clause (i).

           *       *       *       *       *       *       *

                          (vii) For a premarket notification 
                        submission, a fee equal to 1.42 percent 
                        of the fee that applies under [clause 
                        (i), subject to any adjustment under 
                        subsection (c)(3) and any adjustment 
                        under subsection (e)(2)(C)(ii).] clause 
                        (i), subject to any adjustment under 
                        subsection (e)(2)(C)(ii).

           *       *       *       *       *       *       *

                  (D) Refunds.--
                          (i) Application refused for filing.--
                        The Secretary shall refund 75 percent 
                        of the fee paid under subparagraph (A) 
                        for any [application] application, 
                        report, or supplement that is refused 
                        for filing.
                          (ii) Application withdrawn before 
                        filing.--The Secretary shall refund 75 
                        percent of the fee paid under 
                        subparagraph (A) for any [application] 
                        application, report, or supplement that 
                        is withdrawn prior to the filing 
                        decision of the Secretary.

           *       *       *       *       *       *       *

  (d) Small Businesses; Fee Waiver and Fee Reduction Regarding 
Premarket Approval Fees.--
          (1) In general.--The Secretary shall grant a waiver 
        of the fee required under subsection (a) for one 
        premarket application, or one premarket report, where 
        the Secretary finds that the applicant involved is a 
        small business submitting its first premarket 
        application to the Secretary, or its first premarket 
        report, respectively, for review. In addition, for 
        subsequent premarket applications, premarket reports, 
        and supplements where the Secretary finds that the 
        applicant involved is a small business, the fees 
        specified in clauses (i) through (vi) of [subsection 
        (a)(1)(A)] subsection (a)(2)(A) may be paid at a 
        reduced rate in accordance with paragraph (2)(C).
          (2) Rules relating to premarket approval fees.--
                  (A) * * *
                  (B) Evidence of qualification.--An applicant 
                shall pay the higher fees established by the 
                Secretary each year unless the applicant 
                submits evidence that it qualifies for a waiver 
                of the fee or the lower fee rate. The applicant 
                shall support its claim that it meets the 
                definition under subparagraph (A) by submission 
                of a copy of its most recent Federal income tax 
                return for a taxable year, and a copy of such 
                returns of its affiliates, partners, and parent 
                [firms. which show] firms, which show an amount 
                of gross sales or receipts that is less than 
                the maximum established in subparagraph (A). 
                The applicant, and each of such affiliates, 
                partners, and parent firms, shall certify that 
                the information provided is a true and accurate 
                copy of the actual tax forms they submitted to 
                the Internal Revenue Service. If no tax forms 
                are submitted for affiliates, partners, or 
                parent firms, the applicant shall certify that 
                the applicant has no affiliates, partners, or 
                parent firms, respectively.

           *       *       *       *       *       *       *

  (e) Small Businesses; Fee Reduction Regarding Premarket 
Notification Submissions.--
          (1) In general.--[Where] For fiscal year 2004 and 
        each subsequent fiscal year, where the Secretary finds 
        that the applicant involved is a small business, the 
        fee specified in [subsection (a)(1)(A)(vii)] subsection 
        (a)(2)(A)(vii) may be paid at a reduced rate in 
        accordance with paragraph (2)(C).
          (2) Rules relating to premarket notification 
        submissions.--
                  (A) * * *
                  (B) Evidence of qualification.--An applicant 
                shall pay the higher fees established by the 
                Secretary each year unless the applicant 
                submits evidence that it qualifies for the 
                lower fee rate. The applicant shall support its 
                claim that it meets the definition under 
                subparagraph (A) by submission of a copy of its 
                most recent Federal income tax return for a 
                taxable year, and a copy of such returns of its 
                affiliates, partners, and parent [firms. which 
                show] firms, which show an amount of gross 
                sales or receipts that is less than the maximum 
                established in subparagraph (A). The applicant, 
                and each of such affiliates, partners, and 
                parent firms, shall certify that the 
                information provided is a true and accurate 
                copy of the actual tax forms they submitted to 
                the Internal Revenue Service. If no tax forms 
                are submitted for affiliates, partners, or 
                parent firms, the applicant shall certify that 
                the applicant has no affiliates, partners, or 
                parent firms, respectively.
                  (C) Reduced fees.--
                          (i) In general.--[Where] For fiscal 
                        year 2004 and each subsequent fiscal 
                        year, where the Secretary finds that 
                        the applicant involved meets the 
                        definition under subparagraph (A), the 
                        fee for a premarket notification 
                        submission may be paid at 80 percent of 
                        the fee that applies under [subsection 
                        (a)(1)(A)(vii)] subsection 
                        (a)(2)(A)(vii), as adjusted under 
                        clause (ii) and as established under 
                        subsection (c)(5).
                          (ii) Adjustment per fee revenue 
                        amount.--For fiscal year 2004 and each 
                        subsequent fiscal year, the Secretary, 
                        in setting the revenue amount under 
                        subsection (c)(5) for premarket 
                        notification submissions, shall 
                        determine the revenue amount that would 
                        apply if all such submissions for the 
                        fiscal year involved paid a fee equal 
                        to 1.42 percent of the amount that 
                        applies under [subsection (a)(1)(A)(i)] 
                        subsection (a)(2)(A)(i) for premarket 
                        applications, and shall adjust the fee 
                        under [subsection (a)(1)(A)(vii)] 
                        subsection (a)(2)(A)(vii) for premarket 
                        notification submissions such that the 
                        reduced fees collected under clause (i) 
                        of this subparagraph, when added to 
                        fees for such submissions that are not 
                        paid at the reduced rate, will equal 
                        such revenue amount for the fiscal 
                        year.

           *       *       *       *       *       *       *

  (f) Effect of Failure to Pay Fees.--A premarket application, 
premarket report, supplement, or premarket notification 
submission submitted by a person subject to fees under 
subsection (a) shall be considered incomplete and shall not be 
accepted [for filing] by the Secretary until all fees owed by 
such person have been paid.

           *       *       *       *       *       *       *

  (h) Crediting and Availability of Fees.--
          (1) * * *
          (2) Collections and appropriation acts.--
                  (A) * * *
                  (B) Compliance.--[The Secretary]
                          (i) In general.--The Secretary shall 
                        be considered to have met the 
                        requirements of subparagraph (A)(ii) in 
                        any fiscal year if the costs funded by 
                        appropriations and allocated for the 
                        process for the review of device 
                        applications--
                          [(i)] (I) are not more than 3 percent 
                        below the level specified in 
                        subparagraph (A)(ii); or
                          [(ii)(I)] (II)(aa) are more than 3 
                        percent below the level specified in 
                        subparagraph (A)(ii), and fees assessed 
                        for a subsequent fiscal year are 
                        decreased by the amount in excess of 3 
                        percent by which such costs fell below 
                        the level specified in such 
                        subparagraph; and
                          [(II)] (bb) such costs are not more 
                        than 5 percent below the level 
                        specified in such subparagraph.
                          (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.

           *       *       *       *       *       *       *

  (j) Written Requests for Refunds.--To qualify for 
consideration for a refund under [subsection (a)(1)(D),] 
subsection (a)(2)(D), a person shall submit to the Secretary a 
written request for such refund not later than 180 days after 
such fee is due.

           *       *       *       *       *       *       *

                              ----------                              


         MEDICAL DEVICE USER FEE AND MODERNIZATION ACT OF 2002

(Public Law 107-250)

           *       *       *       *       *       *       *


TITLE I--FEES RELATED TO MEDICAL DEVICES

           *       *       *       *       *       *       *


SEC. 102. ESTABLISHMENT OF PROGRAM.

  (a) In General.--Subchapter C of chapter VII of the Federal 
Food, Drug, and Cosmetic Act [(21 U.S.C. 379F et seq.)] (21 
U.S.C. 379f et seq.) is amended by adding at the end the 
following part:

           *       *       *       *       *       *       *

  [(b) Fee Exemption for Certain Entities Submitting Premarket 
Reports.--
          (1) In general.--A person submitting a premarket 
        report]
  (b) Fee Exemption for Certain Entities Submitting Premarket 
Reports.--A person submitting a premarket report to the 
Secretary of Health and Human Services is exempt from the fee 
under [section 738(a)(1)(A)(ii)] section 738(a)(2)(A)(ii) of 
the Federal Food, Drug, and Cosmetic Act (as added by 
subsection (a) of this section) if--
                  [(A)] (1) the premarket report is the first 
                such report submitted to the Secretary by the 
                person; and
                  [(B)] (2) before October 1, 2002, the person 
                submitted a premarket application to the 
                Secretary for the same device as the device for 
                which the person is submitting the premarket 
                report.
          [(2) Definitions.--For purposes of paragraph (1), the 
        terms ``device'', ``premarket application'', and 
        ``premarket report'' have the same meanings as apply to 
        such terms for purposes of section 738 of the Federal 
        Food, Drug, and Cosmetic Act (as added by subsection 
        (a) of this section).]

           *       *       *       *       *       *       *


TITLE II--AMENDMENTS REGARDING REGULATION OF MEDICAL DEVICES

           *       *       *       *       *       *       *


SEC. 210. PEDIATRIC EXPERTISE REGARDING CLASSIFICATION-PANEL REVIEW OF 
                    PREMARKET APPLICATIONS.

  Section 515(c) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360e(c))[, as amended by section 302(c)(2)(A) of 
this Act, is amended in paragraph (3) by adding] is amended in 
paragraph (3), as redesignated by section 302(c)(2)(A) of this 
Act, by adding at the end the following: ``Where appropriate, 
the Secretary shall ensure that such panel includes, or 
consults with, one or more pediatric experts.''.

           *       *       *       *       *       *       *


SEC. 212. STUDY BY INSTITUTE OF MEDICINE OF POSTMARKET SURVEILLANCE 
                    REGARDING PEDIATRIC POPULATIONS.

  (a) * * *
  (b) Certain Matters.--The Secretary shall ensure that 
determinations made in the study under subsection (a) include 
determinations of--
          (1) * * *
          (2) whether the postmarket surveillance by the Food 
        and Drug Administration of medical devices used in 
        pediatric populations is sufficient to provide adequate 
        safeguards for such populations, taking into account 
        the Secretary's monitoring of commitments made at the 
        time of approval of medical devices[, such as phase IV 
        trials,] and the Secretary's monitoring and use of 
        adverse reaction reports, registries, and other 
        postmarket surveillance activities.

           *       *       *       *       *       *       *


                    TITLE III--ADDITIONAL AMENDMENTS

SEC. 301. IDENTIFICATION OF MANUFACTURER OF MEDICAL DEVICES.

  (a) * * *
  (b) Effective Date.--The amendment made by subsection (a) 
takes effect [18 months] 36 months after the date of the 
enactment of this Act, and only applies to devices introduced 
or delivered for introduction into interstate commerce after 
such effective date.

           *       *       *       *       *       *       *