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[107th Congress Public Law 250]
[From the U.S. Government Printing Office]

<DOC>
[DOCID: f:publ250.107]

[[Page 1587]]

          MEDICAL DEVICE USER FEE AND MODERNIZATION ACT OF 2002

[[Page 116 STAT. 1588]]

Public Law 107-250
107th Congress

                                 An Act

 
 To amend the Federal Food, Drug, and Cosmetic Act to make improvements 
          in the regulation of medical devices, and for other 
            purposes. <<NOTE: Oct. 26, 2002 -  [H.R. 5651]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress <<NOTE: Medical Device User Fee and 
Modernization Act of 2002.>> assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This <<NOTE: 21 USC 301 note.>> Act may be cited 
as the ``Medical Device User Fee and Modernization Act of 2002''.

    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.

                TITLE I--FEES RELATED TO MEDICAL DEVICES

Sec. 101. Findings.
Sec. 102. Establishment of program.
Sec. 103. Annual reports.
Sec. 104. Postmarket surveillance.
Sec. 105. Consultation.
Sec. 106. Effective date.
Sec. 107. Sunset clause.

      TITLE II--AMENDMENTS REGARDING REGULATION OF MEDICAL DEVICES

Sec. 201. Inspections by accredited persons.
Sec. 202. Third party review of premarket notification.
Sec. 203. Debarment of accredited persons.
Sec. 204. Designation and regulation of combination products.
Sec. 205. Report on certain devices.
Sec. 206. Electronic labeling.
Sec. 207. Electronic registration.
Sec. 208. Intended use.
Sec. 209. Modular review.
Sec. 210. Pediatric expertise regarding classification-panel review of 
           premarket applications.
Sec. 211. Internet list of class II devices exempted from requirement of 
           premarket notification.
Sec. 212. Study by Institute of Medicine of postmarket surveillance 
           regarding pediatric populations.
Sec. 213. Guidance regarding pediatric devices.
Sec. 214. Breast implants; study by Comptroller General.
Sec. 215. Breast implants; research through National Institutes of 
           Health.

                    TITLE III--ADDITIONAL AMENDMENTS

Sec. 301. Identification of manufacturer of medical devices.
Sec. 302. Single-use medical devices.
Sec. 303. MedWatch.

[[Page 116 STAT. 1589]]

                TITLE I--FEES RELATED TO MEDICAL DEVICES

SEC. 101. <<NOTE: 21 USC 379i note.>> FINDINGS.

    The Congress finds that--
            (1) prompt approval and clearance of safe and effective 
        devices is critical to the improvement of the public health so 
        that patients may enjoy the benefits of devices to diagnose, 
        treat, and prevent disease;
            (2) the public health will be served by making additional 
        funds available for the purpose of augmenting the resources of 
        the Food and Drug Administration that are devoted to the process 
        for the review of devices and the assurance of device safety and 
        effectiveness so that statutorily mandated deadlines may be met; 
        and
            (3) the fees authorized by this title will be dedicated to 
        meeting the goals identified in the letters from the Secretary 
        of Health and Human Services to the Committee on Energy and 
        Commerce of the House of Representatives and the Committee on 
        Health, Education, Labor, and Pensions of the Senate, as set 
        forth in the Congressional Record.

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.) is amended by adding at 
the end the following part:

                   ``PART 3--FEES RELATING TO DEVICES

``SEC. 737. <<NOTE: 21 USC 379i.>> DEFINITIONS.

    ``For purposes of this subchapter:
            ``(1) The term `premarket application' means--
                    ``(A) an application for approval of a device 
                submitted under section 515(c) or section 351 of the 
                Public Health Service Act; or
                    ``(B) a product development protocol described in 
                section 515(f).
        Such term does not include a supplement, a premarket report, or 
        a premarket notification submission.
            ``(2) The term `premarket report' means a report submitted 
        under section 515(c)(2).
            ``(3) The term `premarket notification submission' means a 
        report submitted under section 510(k).
            ``(4)(A) The term `supplement', with respect to a panel-
        track supplement, a 180-day supplement, a real-time supplement, 
        or an efficacy supplement, means a request to the Secretary to 
        approve a change in a device for which--
                    ``(i) an application or report has been approved 
                under section 515(d), or an application has been 
                approved under section 351 of the Public Health Service 
                Act; or
                    ``(ii) a notice of completion has become effective 
                under section 515(f).
            ``(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

[[Page 116 STAT. 1590]]

        the device, and for which clinical data are generally necessary 
        to provide a reasonable assurance of safety and effectiveness.
            ``(C) The term `180-day supplement' means a supplement to an 
        approved premarket application or premarket report under section 
        515 that is not a panel-track supplement and requests a 
        significant change in components, materials, design, 
        specification, software, color additives, or labeling.
            ``(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.
            ``(E) The term `efficacy supplement' means a supplement to 
        an approved premarket application under section 351 of the 
        Public Health Service Act that requires substantive clinical 
        data.
            ``(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) The activities necessary for the review of 
                premarket applications, premarket reports, supplements, 
                and premarket notification submissions.
                    ``(B) The issuance of action letters that allow the 
                marketing of devices or which set forth in detail the 
                specific deficiencies in such applications, reports, 
                supplements, or submissions and, where appropriate, the 
                actions necessary to place them in condition for 
                approval.
                    ``(C) The inspection of manufacturing establishments 
                and other facilities undertaken as part of the 
                Secretary's review of pending premarket applications, 
                premarket reports, and supplements.
                    ``(D) Monitoring of research conducted in connection 
                with the review of such applications, reports, 
                supplements, and submissions.
                    ``(E) Review of device applications subject to 
                section 351 of the Public Health Service Act for an 
                investigational new drug application under section 
                505(i) or for an investigational device exemption under 
                section 520(g) and activities conducted in anticipation 
                of the submission of such applications under section 
                505(i) or 520(g).
                    ``(F) The development of guidance, policy documents, 
                or regulations to improve the process for the review of 
                premarket applications, premarket reports, supplements, 
                and premarket notification submissions.
                    ``(G) The development of voluntary test methods, 
                consensus standards, or mandatory performance standards 
                under section 514 in connection with the review of such 
                applications, reports, supplements, or submissions and 
                related activities.
                    ``(H) The provision of technical assistance to 
                device manufacturers in connection with the submission 
                of such applications, reports, supplements, or 
                submissions.

[[Page 116 STAT. 1591]]

                    ``(I) Any activity undertaken under section 513 or 
                515(i) in connection with the initial classification or 
                reclassification of a device or under section 515(b) in 
                connection with any requirement for approval of a 
                device.
                    ``(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.
                    ``(K) Compiling, developing, and reviewing 
                information on relevant devices to identify safety and 
                effectiveness issues for devices subject to premarket 
                applications, premarket reports, supplements, or 
                premarket notification submissions.
            ``(6) The term `costs of resources allocated for the process 
        for the review of device applications' means the expenses 
        incurred in connection with the process for the review of device 
        applications for--
                    ``(A) officers and employees of the Food and Drug 
                Administration, contractors of the Food and Drug 
                Administration, advisory committees, and costs related 
                to such officers, employees, and committees and to 
                contracts with such contractors;
                    ``(B) management of information, and the 
                acquisition, maintenance, and repair of computer 
                resources;
                    ``(C) leasing, maintenance, renovation, and repair 
                of facilities and acquisition, maintenance, and repair 
                of fixtures, furniture, scientific equipment, and other 
                necessary materials and supplies; and
                    ``(D) collecting fees and accounting for resources 
                allocated for the review of premarket applications, 
                premarket reports, supplements, and submissions.
            ``(7) The term `adjustment factor' applicable to a fiscal 
        year is the Consumer Price Index for all urban consumers (all 
        items; United States city average) for April of the preceding 
        fiscal year divided by such Index for April 2002.
            ``(8) The term `affiliate' means a business entity that has 
        a relationship with a second business entity if, directly or 
        indirectly--
                    ``(A) one business entity controls, or has the power 
                to control, the other business entity; or
                    ``(B) a third party controls, or has power to 
                control, both of the business entities.

``SEC. 738. <<NOTE: 21 USC 379j.>> AUTHORITY TO ASSESS AND USE DEVICE 
            FEES.

    ``(a) Types of Fees.--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:
            ``(1) Premarket application, premarket report, supplement, 
        and submission fee.--
                    ``(A) In general.--Except as provided in 
                subparagraph (B) and subsection (d), 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) A premarket application.

[[Page 116 STAT. 1592]]

                          ``(ii) For a premarket report, a fee equal to 
                      the fee that applies under clause (i).
                          ``(iii) For a panel track supplement, a fee 
                      equal to the fee that applies under clause (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).
                          ``(v) For a real-time supplement, a fee equal 
                      to 7.2 percent of the fee that applies under 
                      clause (i).
                          ``(vi) For an efficacy supplement, a fee equal 
                      to the fee that applies under 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).
                    ``(B) Exceptions.--
                          ``(i) Humanitarian device exemption.--An 
                      application under section 520(m) is not subject to 
                      any fee under subparagraph (A).
                          ``(ii) Further manufacturing use.--No fee 
                      shall be required under subparagraph (A) for the 
                      submission of a premarket application under 
                      section 351 of the Public Health Service Act for a 
                      product licensed for further manufacturing use 
                      only.
                          ``(iii) State or federal government 
                      sponsors.--No fee shall be required under 
                      subparagraph (A) for a premarket application, 
                      premarket report, supplement, or premarket 
                      notification submission submitted by a State or 
                      Federal Government entity unless the device 
                      involved is to be distributed commercially.
                          ``(iv) Premarket notifications by third 
                      parties.--No fee shall be required under 
                      subparagraph (A) for a premarket notification 
                      submission reviewed by an accredited person 
                      pursuant to section 523.
                          ``(v) Pediatric conditions of use.--
                                    ``(I) In general.--No fee shall be 
                                required under subparagraph (A) for a 
                                premarket application, premarket report, 
                                or premarket notification submission if 
                                the proposed conditions of use for the 
                                device involved are solely for a 
                                pediatric population. No fee shall be 
                                required under such subparagraph for a 
                                supplement if the sole purpose of the 
                                supplement is to propose conditions of 
                                use for a pediatric population.
                                    ``(II) Subsequent proposal of adult 
                                conditions of use.--In the case of a 
                                person who submits a premarket 
                                application or premarket report for 
                                which, under subclause (I), a fee under 
                                subparagraph (A) is not required, any 
                                supplement to such application that 
                                proposes conditions of use for any adult 
                                population is subject to the fee that 
                                applies under such subparagraph for a 
                                premarket application.
                    ``(C) Payment.--The fee required by subparagraph (A) 
                shall be due upon submission of the premarket 
                application, premarket report, supplement, or premarket 
                notification submission except that invoices for 
                applications submitted

[[Page 116 STAT. 1593]]

                between October 1, 2002, and the date of the enactment 
                of the Medical Device User Fee and Modernization Act of 
                2002 shall be payable on October 30, 2002. Applicants 
                submitting portions of applications pursuant to section 
                515(c)(3) shall pay such fees upon submission of the 
                first portion of such applications. The fees credited to 
                fiscal year 2003 under this section shall include all 
                fees payable from October 1, 2002, through September 30, 
                2003.
                    ``(D) Refunds.--
                          ``(i) Application refused for filing.--The 
                      Secretary shall refund 75 percent of the fee paid 
                      under subparagraph (A) for any application 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 or 
                      supplement that is withdrawn prior to the filing 
                      decision of the Secretary.
                          ``(iii) Application withdrawn before first 
                      action.--After receipt of a request for a refund 
                      of the fee paid under subparagraph (A) for a 
                      premarket application, premarket report, or 
                      supplement that is withdrawn after filing but 
                      before a first action, the Secretary may return 
                      some or all of the fee. The amount of refund, if 
                      any, shall be based on the level of effort already 
                      expended on the review of such application, 
                      report, or supplement. The Secretary shall have 
                      sole discretion to refund a fee or portion of the 
                      fee under this subparagraph. A determination by 
                      the Secretary concerning a refund under this 
                      paragraph shall not be reviewable.

    ``(b) Fee Revenue Amounts.--Except as provided in subsections (c), 
(d), (e), (g), and (h), the fees under subsection (a) shall be 
established to generate the following revenue amounts: $25,125,000 in 
fiscal year 2003; $27,255,000 in fiscal year 2004; $29,785,000 in fiscal 
year 2005; $32,615,000 in fiscal year 2006, and $35,000,000 in fiscal 
year 2007. If legislation is enacted after the date of the enactment of 
the Medical Device User Fee and Modernization Act of 2002 requiring the 
Secretary to fund additional costs of the retirement of Federal 
personnel, fee revenue amounts under this subsection shall be increased 
in each year by the amount necessary to fully fund the portion of such 
additional costs that are attributable to the process for the review of 
device applications.
    ``(c) Adjustments.--
            ``(1) Inflation adjustment.--The <<NOTE: Federal Register, 
        publication.>> revenues established in subsection (b) shall be 
        adjusted by the Secretary by notice, published in the Federal 
        Register, for a fiscal year to reflect the greater of--
                    ``(A) the total percentage change that occurred in 
                the Consumer Price Index for all urban consumers (all 
                items; U.S. city average) for the 12 month period ending 
                June 30 preceding the fiscal year for which fees are 
                being established, or
                    ``(B) the total percentage change for the previous 
                fiscal year in basic pay under the General Schedule in 
                accordance with section 5332 of title 5, United States 
                Code, as adjusted

[[Page 116 STAT. 1594]]

                by any locality-based comparability payment pursuant to 
                section 5304 of such title for Federal employees 
                stationed in the District of Columbia.
        The adjustment made each fiscal year by this subsection shall be 
        added on a compounded basis to the sum of all adjustments made 
        each fiscal year after fiscal year 2003 under this subsection.
            ``(2) Workload adjustment.--After the fee revenues 
        established in subsection (b) are adjusted for a fiscal year for 
        inflation in accordance with paragraph (1), the fee revenues 
        shall, beginning with fiscal year 2004, be adjusted further each 
        fiscal year to reflect changes in the workload of the Secretary 
        for the process for the review of device applications. With 
        respect to such adjustment:
                    ``(A) The adjustment shall be determined by the 
                Secretary based on a weighted average of the change in 
                the total number of premarket applications, 
                investigational new device applications, premarket 
                reports, supplements, and premarket notification 
                submissions submitted to the Secretary. <<NOTE: Federal 
                Register, publication.>> The Secretary shall publish in 
                the Federal Register the fee revenues and fees resulting 
                from the adjustment and the supporting methodologies.
                    ``(B) Under no circumstances shall the adjustment 
                result in fee revenues for a fiscal year that are less 
                than the fee revenues for the fiscal year established in 
                subsection (b), as adjusted for inflation under 
                paragraph (1).
            ``(3) Compensating adjustment.--After the fee revenues 
        established in subsection (b) are adjusted for a fiscal year for 
        inflation in accordance with paragraph (1), and for workload in 
        accordance with paragraph (2), the fee revenues shall, beginning 
        with fiscal year 2004, be adjusted further each fiscal year, if 
        necessary, to reflect the cumulative amount by which collections 
        for previous fiscal years, beginning with fiscal year 2003, fell 
        below the cumulative revenue amounts for such fiscal years 
        specified in subsection (b), adjusted for such fiscal years for 
        inflation in accordance with paragraph (1), and for workload in 
        accordance with paragraph (2).
            ``(4) Final year adjustment.--For fiscal year 2007, the 
        Secretary may, in addition to adjustments under paragraphs (1) 
        and (2), further increase the fees and fee revenues established 
        in subsection (b) if such adjustment is necessary to provide for 
        not more than three months of operating reserves of carryover 
        user fees for the process for the review of device applications 
        for the first three months of fiscal year 2008. If such an 
        adjustment is necessary, the rationale for the amount of the 
        increase shall be contained in the annual notice establishing 
        fee revenues and fees for fiscal year 2007. If the Secretary has 
        carryover user fee balances for such process in excess of three 
        months of such operating reserves, the adjustment under this 
        paragraph shall not be made.
            ``(5) Annual fee setting.--The <<NOTE: Federal Register, 
        publication.>> Secretary shall, 60 days before the start of each 
        fiscal year after September 30, 2002, establish, for the next 
        fiscal year, and publish in the Federal Register, fees under 
        subsection (a), based on the revenue amounts established under 
        subsection (b) and the adjustment provided under this subsection 
        and subsection (e)(2)(C)(ii),

[[Page 116 STAT. 1595]]

        except that the fees established for fiscal year 2003 shall be 
        based on a premarket application fee of $154,000.
            ``(6) Limit.--The total amount of fees charged, as adjusted 
        under this subsection, for a fiscal year may not exceed the 
        total costs for such fiscal year for the resources allocated for 
        the process for the review of device applications.

    ``(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) may be paid at a reduced rate in accordance 
        with paragraph (2)(C).
            ``(2) Rules relating to premarket approval fees.--
                    ``(A) Definition.--
                          ``(i) In general.--For purposes of this 
                      subsection, the term `small business' means an 
                      entity that reported $30,000,000 or less of gross 
                      receipts or sales in its most recent Federal 
                      income tax return for a taxable year, including 
                      such returns of all of its affiliates, partners, 
                      and parent firms.
                          ``(ii) Adjustment.--The Secretary may adjust 
                      the $30,000,000 threshold established in clause 
                      (i) if the Secretary has evidence from actual 
                      experience that this threshold results in a 
                      reduction in revenues from premarket applications, 
                      premarket reports, and supplements that is 16 
                      percent or more than would occur without small 
                      business exemptions and lower fee rates. To 
                      adjust <<NOTE: Federal Register, 
                      publication. Notice.>> this threshold, the 
                      Secretary shall publish a notice in the Federal 
                      Register setting out the rationale for the 
                      adjustment, and the new threshold.
                    ``(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 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.--Where the Secretary finds that 
                the applicant involved meets the definition under 
                subparagraph (A), the fees established under subsection 
                (c)(5) may

[[Page 116 STAT. 1596]]

                be paid at a reduced rate of 38 percent of the fee 
                established under such subsection for a premarket 
                application, a premarket report, or a supplement.
                    ``(D) Request for fee waiver or reduction.--An 
                applicant seeking a fee waiver or reduction under this 
                subsection shall submit supporting information to the 
                Secretary at least 60 days before the fee is required 
                pursuant to subsection (a). The decision of the 
                Secretary regarding whether an entity qualifies for such 
                a waiver or reduction is not reviewable.

    ``(e) Small Businesses; Fee Reduction Regarding Premarket 
Notification Submissions.--
            ``(1) In general.--Where the Secretary finds that the 
        applicant involved is a small business, the fee specified in 
        subsection (a)(1)(A)(vii) may be paid at a reduced rate in 
        accordance with paragraph (2)(C).
            ``(2) Rules relating to premarket notification 
        submissions.--
                    ``(A) Definition.--For purposes of this subsection, 
                the term `small business' means an entity that reported 
                $30,000,000 or less of gross receipts or sales in its 
                most recent Federal income tax return for a taxable 
                year, including such returns of all of its affiliates, 
                partners, and parent firms.
                    ``(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 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 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), 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) for premarket

[[Page 116 STAT. 1597]]

                      applications, and shall adjust the fee under 
                      subsection (a)(1)(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.
                    ``(D) Request for reduction.--An applicant seeking a 
                fee reduction under this subsection shall submit 
                supporting information to the Secretary at least 60 days 
                before the fee is required pursuant to subsection (a). 
                The decision of the Secretary regarding whether an 
                entity qualifies for such a reduction is not reviewable.

    ``(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.
    ``(g) Conditions.--
            ``(1) Performance goals through fiscal year 2005; 
        termination of program after fiscal year 2005.--With respect to 
        the amount that, under the salaries and expenses account of the 
        Food and Drug Administration, is appropriated for a fiscal year 
        for devices and radiological products:
                    ``(A)(i) For each of the fiscal years 2003 and 2004, 
                the Secretary is expected to meet all of the goals 
                identified for the fiscal year involved in any letter 
                referred to in section 101(3) of the Medical Device User 
                Fee and Modernization Act of 2002 (referred to in this 
                paragraph as `performance goals') if the amount so 
                appropriated for such fiscal year, excluding the amount 
                of fees appropriated for such fiscal year, is equal to 
                or greater than $205,720,000 multiplied by the 
                adjustment factor applicable to the fiscal year.
                    ``(ii) For each of the fiscal years 2003 and 2004, 
                if the amount so appropriated for the fiscal year 
                involved, excluding the amount of fees appropriated for 
                such fiscal year, is less than the amount that applies 
                under clause (i) for such fiscal year, the following 
                applies:
                          ``(I) The Secretary is expected to meet such 
                      goals to the extent practicable, taking into 
                      account the amounts that are available to the 
                      Secretary for such purpose, whether from fees 
                      under subsection (a) or otherwise.
                          ``(II) <<NOTE: Reports.>> The Comptroller 
                      General of the United States shall submit to the 
                      Congress a report describing whether and to what 
                      extent the Secretary is meeting the performance 
                      goals identified for such fiscal year, and whether 
                      the Secretary will be able to meet all performance 
                      goals identified for <<NOTE: Deadline.>> fiscal 
                      year 2005. A report under the preceding sentence 
                      shall be submitted to the Congress not later than 
                      July 1 of the fiscal year with which the report is 
                      concerned.
                    ``(B)(i) For fiscal year 2005, the Secretary is 
                expected to meet all of the performance goals identified 
                for the fiscal year if the total of the amounts so 
                appropriated for fiscal years 2003 through 2005, 
                excluding the amount

[[Page 116 STAT. 1598]]

                of fees appropriated for such fiscal years, is equal to 
                or greater than the sum of--
                          ``(I) $205,720,000 multiplied by the 
                      adjustment factor applicable to fiscal year 2003;
                          ``(II) $205,720,000 multiplied by the 
                      adjustment factor applicable to fiscal year 2004; 
                      and
                          ``(III) $205,720,000 multiplied by the 
                      adjustment factor applicable to fiscal year 2005.
                    ``(ii) For fiscal year 2005, if the total of the 
                amounts so appropriated for fiscal years 2003 through 
                2005, excluding the amount of fees appropriated for such 
                fiscal years, is less than the sum that applies under 
                clause (i) for fiscal year 2005, the following applies:
                          ``(I) The Secretary is expected to meet such 
                      goals to the extent practicable, taking into 
                      account the amounts that are available to the 
                      Secretary for such purpose, whether from fees 
                      under subsection (a) or otherwise.
                          ``(II) <<NOTE: Reports.>> The Comptroller 
                      General of the United States shall submit to the 
                      Congress a report describing whether and to what 
                      extent the Secretary is meeting the performance 
                      goals identified for such fiscal year, and whether 
                      the Secretary will be able to meet all performance 
                      goals identified for <<NOTE: Deadline.>> fiscal 
                      year 2006. The report under the preceding sentence 
                      shall be submitted to the Congress not later than 
                      July 1, 2005.
                    ``(C) For fiscal year 2006, fees may not be assessed 
                under subsection (a) for the fiscal year, and the 
                Secretary is not expected to meet any performance goals 
                identified for the fiscal year, if the total of the 
                amounts so appropriated for fiscal years 2003 through 
                2006, excluding the amount of fees appropriated for such 
                fiscal years, is less than the sum of--
                          ``(i) $205,720,000 multiplied by the 
                      adjustment factor applicable to fiscal year 2006; 
                      and
                          ``(ii) an amount equal to the sum that applies 
                      for purposes of subparagraph (B)(i).
                    ``(D) For fiscal year 2007, fees may not be assessed 
                under subsection (a) for the fiscal year, and the 
                Secretary is not expected to meet any performance goals 
                identified for the fiscal year, if--
                          ``(i) the amount so appropriated for the 
                      fiscal year, excluding the amount of fees 
                      appropriated for the fiscal year, is less than 
                      $205,720,000 multiplied by the adjustment factor 
                      applicable to fiscal year 2007; or
                          ``(ii) pursuant to subparagraph (C), fees were 
                      not assessed under subsection (a) for fiscal year 
                      2006.
            ``(2) Authority.--If the Secretary does not assess fees 
        under subsection (a) during any portion of a fiscal year because 
        of subparagraph (C) or (D) of paragraph (1) and if at a later 
        date in such fiscal year the Secretary may assess such fees, the 
        Secretary may assess and collect such fees, without any 
        modification in the rate for premarket applications, 
        supplements, premarket reports, and premarket notification 
        submissions, and at any time in such fiscal year, 
        notwithstanding the provisions of subsection (a) relating to the 
        date fees are to be paid.

[[Page 116 STAT. 1599]]

    ``(h) Crediting and Availability of Fees.--
            ``(1) In general.--Fees authorized under subsection (a) 
        shall be collected and available for obligation only to the 
        extent and in the amount provided in advance in appropriation 
        Acts. Such fees are authorized to be appropriated to remain 
        available until expended. Such sums as may be necessary may be 
        transferred from the Food and Drug Administration salaries and 
        expenses appropriation account without fiscal year limitation to 
        such appropriation account for salaries and expenses with such 
        fiscal year limitation. The sums transferred shall be available 
        solely for the process for the review of device applications.
            ``(2) Collections and appropriation acts.--
                    ``(A) In general.--The fees authorized by this 
                section--
                          ``(i) shall be retained in each fiscal year in 
                      an amount not to exceed the amount specified in 
                      appropriation Acts, or otherwise made available 
                      for obligation, for such fiscal year, and
                          ``(ii) shall only be collected and available 
                      to defray increases in the costs of the resources 
                      allocated for the process for the review of device 
                      applications (including increases in such costs 
                      for an additional number of full-time equivalent 
                      positions in the Department of Health and Human 
                      Services to be engaged in such process) over such 
                      costs, excluding costs paid from fees collected 
                      under this section, for fiscal year 2002 
                      multiplied by the adjustment factor.
                    ``(B) Compliance.--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) are not more than 3 percent below the 
                      level specified in subparagraph (A)(ii); or
                          ``(ii)(I) 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) such costs are not more than 5 percent 
                      below the level specified in such subparagraph.
            ``(3) Authorization of appropriations.--There are authorized 
        to be appropriated for fees under this section--
                    ``(A) $25,125,000 for fiscal year 2003;
                    ``(B) $27,255,000 for fiscal year 2004;
                    ``(C) $29,785,000 for fiscal year 2005;
                    ``(D) $32,615,000 for fiscal year 2006; and
                    ``(E) $35,000,000 for fiscal year 2007,
        as adjusted to reflect adjustments in the total fee revenues 
        made under this section and changes in the total amounts 
        collected by application fees.
            ``(4) Offset.--Any amount of fees collected for a fiscal 
        year under this section that exceeds the amount of fees 
        specified in appropriation Acts for such fiscal year shall be 
        credited to the appropriation account of the Food and Drug 
        Administration as provided in paragraph (1), and shall be 
        subtracted

[[Page 116 STAT. 1600]]

        from the amount of fees that would otherwise be authorized to be 
        collected under this section pursuant to appropriation Acts for 
        a subsequent fiscal year.

    ``(i) Collection of Unpaid Fees.--In <<NOTE: Deadline.>> any case 
where the Secretary does not receive payment of a fee assessed under 
subsection (a) within 30 days after it is due, such fee shall be treated 
as a claim of the United States Government subject to subchapter II of 
chapter 37 of title 31, United States Code.

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

    ``(k) Construction.--This section may not be construed to require 
that the number of full-time equivalent positions in the Department of 
Health and Human Services, for officers, employees, and advisory 
committees not engaged in the process of the review of device 
applications, be reduced to offset the number of officers, employees, 
and advisory committees so engaged.''.
    (b) Fee <<NOTE: 21 USC 379j note.>> Exemption for Certain Entities 
Submitting Premarket Reports.--
            (1) In general.--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) of the Federal Food, Drug, 
        and Cosmetic Act (as added by subsection (a) of this section) 
        if--
                    (A) the premarket report is the first such report 
                submitted to the Secretary by the person; and
                    (B) 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).

SEC. 103. <<NOTE: 21 USC 379i note.>> ANNUAL REPORTS.

    Beginning with fiscal year 2003, the Secretary shall prepare and 
submit 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 report concerning--
            (1) the progress of the Food and Drug Administration in 
        achieving the goals identified in the letters described in 
        section 101(3) during such fiscal year and the future plans of 
        the Food and Drug Administration for meeting the goals, not 
        later than 60 days after the end of each fiscal year during 
        which fees are collected under this part; and
            (2) <<NOTE: Deadline.>> the implementation of the authority 
        for such fees during such fiscal year, and the use, by the Food 
        and Drug Administration, of the fees collected during such 
        fiscal year, not later than 120 days after the end of each 
        fiscal year during which fees are collected under the medical 
        device user-fee program established under the amendment made by 
        section 102.

SEC. 104. POSTMARKET SURVEILLANCE.

    (a) Additional Authorization of Appropriations.--For the purpose of 
carrying out postmarket surveillance of medical devices,

[[Page 116 STAT. 1601]]

there are authorized to be appropriated to the Food and Drug 
Administration the following amounts, stated as increases above the 
amount obligated for such purpose by such Administration for fiscal year 
2002:
            (1) For fiscal year 2003, an increase of $3,000,000.
            (2) For fiscal year 2004, an increase of $6,000,000.
            (3) For fiscal year 2005 and each subsequent fiscal year, an 
        increase of such sums as may be necessary.

    (b) <<NOTE: 21 USC 379i note.>> Study.--
            (1) In general.--The Secretary of Health and Human Services 
        (referred to in this section as the ``Secretary'') shall conduct 
        a study for the purpose of determining the following with 
        respect to the medical device user-fee program established under 
        the amendment made by section 102:
                    (A) The impact of such program on the ability of the 
                Food and Drug Administration to conduct postmarket 
                surveillance on medical devices.
                    (B) The programmatic improvements, if any, needed 
                for adequate postmarket surveillance of medical devices.
                    (C) The amount of funds needed to conduct adequate 
                postmarket surveillance of medical devices.
                    (D) The extent to which device companies comply with 
                the postmarket surveillance requirements, including 
                postmarket study commitments.
                    (E) The recommendations of the Secretary as to 
                whether, and in what amounts, user fees collected under 
                such user-fee program should be dedicated to postmarket 
                surveillance if the program is extended beyond fiscal 
                year 2007.
            (2) Report.--Not <<NOTE: Deadline.>> later than January 10, 
        2007, the Secretary shall submit 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 report 
        that describes the findings of the study under paragraph (1).

SEC. 105. <<NOTE: 21 USC 379i note.>> CONSULTATION.

    (a) In General.--In developing recommendations to the Congress for 
the goals and plans for meeting the goals for the process for the review 
of medical device applications for fiscal years after fiscal year 2007, 
and for the reauthorization of sections 737 and 738 of the Federal Food, 
Drug, and Cosmetic Act, the Secretary of Health and Human Services 
(referred to in this section as the ``Secretary'') shall consult with 
the Committee on Energy and Commerce of the House of Representatives, 
the Committee on Health, Education, Labor, and Pensions of the Senate, 
appropriate scientific and academic experts, health care professionals, 
representatives of patient and consumer advocacy groups, and the 
regulated industry.
    (b) Recommendations.--The <<NOTE: Federal Register, 
publication.>> Secretary shall publish in the Federal Register 
recommendations under subsection (a), after negotiations with the 
regulated industry; shall present such recommendations to the 
congressional committees specified in such paragraph; shall hold a 
meeting at which the public may present its views on such 
recommendations; and shall provide for a period of 30 days for the 
public to provide written comments on such recommendations.

[[Page 116 STAT. 1602]]

SEC. 106. <<NOTE: 21 USC 379i note.>> EFFECTIVE DATE.

    The amendments made by this title shall take effect on the date of 
the enactment of this Act, except that fees shall be assessed for all 
premarket applications, premarket reports, supplements, and premarket 
notification submissions received on or after October 1, 2002, 
regardless of the date of enactment.

SEC. 107. <<NOTE: 21 USC 379i note.>> SUNSET CLAUSE.

    The amendments made by this title cease to be effective October 1, 
2007, except that section 103 with respect to annual reports ceases to 
be effective January 31, 2008.

      TITLE II--AMENDMENTS REGARDING REGULATION OF MEDICAL DEVICES

SEC. 201. INSPECTIONS BY ACCREDITED PERSONS.

    (a) In General.--Section 704 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 374) is amended by adding at the end the following 
subsection:
    ``(g)(1) <<NOTE: Deadline.>> 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). 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.

    ``(2) <<NOTE: Deadline. Federal Register, publication.>> Not later 
than 180 days after the date of enactment of this subsection, the 
Secretary shall publish in the Federal Register criteria to accredit or 
deny accreditation to persons who request to perform the duties 
specified in paragraph (1). Thereafter, the Secretary shall inform those 
requesting accreditation, within 60 days after the receipt of such 
request, whether the request for accreditation is adequate for review, 
and the Secretary shall promptly act on the request for accreditation. 
Any resulting accreditation shall state that such person is accredited 
to conduct inspections at device establishments identified in paragraph 
(1). The accreditation of such person shall specify the particular 
activities under this subsection for which such person is accredited. In 
the first year following the publication in the Federal Register of 
criteria to accredit or deny accreditation to persons who request to 
perform the duties specified in paragraph (1), the Secretary shall 
accredit no more than 15 persons who request to perform duties specified 
in paragraph (1).

    ``(3) An accredited person shall, at a minimum, meet the following 
requirements:
            ``(A) Such person may not be an employee of the Federal 
        Government.
            ``(B) Such person shall be an independent organization which 
        is not owned or controlled by a manufacturer, supplier, or 
        vendor of articles regulated under this Act and which has no 
        organizational, material, or financial affiliation (including a 
        consultative affiliation) with such a manufacturer, supplier, or 
        vendor.

[[Page 116 STAT. 1603]]

            ``(C) Such person shall be a legally constituted entity 
        permitted to conduct the activities for which it seeks 
        accreditation.
            ``(D) Such person shall not engage in the design, 
        manufacture, promotion, or sale of articles regulated under this 
        Act.
            ``(E) The operations of such person shall be in accordance 
        with generally accepted professional and ethical business 
        practices, and such person shall agree in writing that at a 
        minimum the person will--
                    ``(i) certify that reported information accurately 
                reflects data reviewed, inspection observations made, 
                other matters that relate to or may influence compliance 
                with this Act, and recommendations made during an 
                inspection or at an inspection's closing meeting;
                    ``(ii) limit work to that for which competence and 
                capacity are available;
                    ``(iii) treat information received, records, 
                reports, and recommendations as confidential commercial 
                or financial information or trade secret information, 
                except such information may be made available to the 
                Secretary;
                    ``(iv) promptly respond and attempt to resolve 
                complaints regarding its activities for which it is 
                accredited; and
                    ``(v) protect against the use, in carrying out 
                paragraph (1), of any officer or employee of the 
                accredited person who has a financial conflict of 
                interest regarding any product regulated under this Act, 
                and annually make available to the public disclosures of 
                the extent to which the accredited person, and the 
                officers and employees of the person, have maintained 
                compliance with requirements under this clause relating 
                to financial conflicts of interest.

    ``(4) <<NOTE: Publication.>> The Secretary shall publish on the 
Internet site of the Food and Drug Administration a list of persons who 
are accredited under paragraph (2). Such list shall be updated to ensure 
that the identity of each accredited person, and the particular 
activities for which the person is accredited, is known 
to <<NOTE: Deadline.>> the public. The updating of such list shall be no 
later than one month after the accreditation of a person under this 
subsection or the suspension or withdrawal of accreditation, or the 
modification of the particular activities for which the person is 
accredited.

    ``(5)(A) To ensure that persons accredited under this subsection 
continue to meet the standards of accreditation, the Secretary shall (i) 
audit the performance of such persons on a periodic basis through the 
review of inspection reports and inspections by persons designated by 
the Secretary to evaluate the compliance status of a device 
establishment and the performance of accredited persons, and (ii) take 
such additional measures as the Secretary determines to be appropriate.
    ``(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. The Secretary may suspend the accreditation 
of such person during the pendency of the process under the preceding 
sentence.

[[Page 116 STAT. 1604]]

    ``(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 as `no action indicated' or `voluntary 
        action indicated'.
            ``(ii) With respect to each inspection to be conducted by an 
        accredited person--
                    ``(I) the owner or operator of the establishment 
                submits to the Secretary a notice requesting clearance 
                to use such a person to conduct the inspection, and the 
                Secretary provides such clearance; and
                    ``(II) such notice identifies the accredited person 
                whom the establishment has selected to conduct the 
                inspection, and the Secretary agrees to the selected 
                accredited person.
            ``(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:
                    ``(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.
                    ``(II) <<NOTE: Deadline.>> 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, 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 510(h), persons accredited under paragraph (2) did 
        not conduct the two immediately preceding inspections of the 
        establishment, 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 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 after the Secretary has conducted an inspection of 
        the establishment.

[[Page 116 STAT. 1605]]

            ``(II) In the case of an inspection to be conducted pursuant 
        to 510(i), the Secretary periodically conducts inspections of 
        the establishment.

    ``(B)(i) <<NOTE: Deadline.>> The Secretary shall respond to a notice 
under subparagraph (A) from a device establishment not later than 30 
days after the Secretary receives the notice. Through such response, the 
Secretary shall (I) provide clearance under such subparagraph, and agree 
to the selection of an accredited person, or (II) make a request under 
clause (ii). If the Secretary fails to respond to the notice within such 
30-day period, the establishment is deemed to have such clearance, and 
to have the agreement of the Secretary for such selection.

    ``(ii) The request referred to in clause (i)(II) is--
            ``(I) a request to the device establishment involved to 
        submit to the Secretary compliance data in accordance with 
        clause (iii); or
            ``(II) a request to the establishment, or to the accredited 
        person identified in the notice under subparagraph (A), for 
        information concerning the relationship between the 
        establishment and such accredited person, including information 
        about the number of inspections of the establishment, or other 
        establishments owned or operated by the owner or operator of the 
        establishment, that have been conducted by the accredited 
        person.

The Secretary may make both such requests.
    ``(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 applicable provisions of this Act. Such data shall include 
complete reports of inspections 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 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) <<NOTE: Deadline.>> 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.

    ``(v)(I) A request to an accredited person under clause (ii)(II) may 
not seek any information that is not required to be maintained by such 
person in records under subsection (f)(1). Not later than 60 days after 
receiving the information sought by the request, the Secretary shall 
agree to, or reject, the selection of such person by the device 
establishment involved. The Secretary may reject

[[Page 116 STAT. 1606]]

the selection if the Secretary provides to the establishment a statement 
of the reasons for such rejection. Reasons for the rejection may include 
that the establishment or the accredited person, as the case may be, has 
failed to fully respond to the request, or that the Secretary has 
concerns regarding the relationship between the establishment and such 
accredited person. If within such 60-day period the Secretary fails to 
agree to or reject the selection in accordance with this subclause, the 
Secretary is deemed to have agreed to the selection.
    ``(II) If the Secretary rejects the selection of an accredited 
person by a device establishment, the establishment may make an 
additional selection of an accredited person by submitting to the 
Secretary a notice that identifies the additional selection. Clauses (i) 
and (ii), and subclause (I) of this clause, apply to the selection of an 
accredited person through a notice under the preceding sentence in the 
same manner and to the same extent as such provisions apply to a 
selection of an accredited person through a notice under subparagraph 
(A).
    ``(vi) In the case of a device establishment that under clause (iv) 
is denied clearance under subparagraph (A), or whose selection of an 
accredited person is rejected under clause (v), the Secretary shall 
designate a person to review the findings of the Secretary under such 
clause if, during the 30-day period beginning on the date on which the 
establishment receives the findings, the establishment requests the 
review. <<NOTE: Deadline.>> The review shall commence not later than 30 
days after the establishment requests the review, unless the Secretary 
and the establishment otherwise agree.

    ``(C)(i) In the case of a device establishment for which the 
Secretary classified the results of the most recent inspection of the 
establishment by a person accredited under paragraph (2) as `official 
action indicated', the establishment, if otherwise eligible under 
subparagraph (A), is eligible for further inspections by persons 
accredited under such paragraph if (I) the Secretary issues a written 
statement to the owner or operator of the establishment that the 
violations leading to such classification have been resolved, and (II) 
the Secretary, either upon the Secretary's own initiative or a petition 
of the owner or operator of the establishment, notifies the 
establishment that it has clearance to use an accredited person for the 
inspections. The Secretary shall respond to such petition within 30 days 
after the receipt of the petition.
    ``(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.
    ``(7)(A) Persons accredited under paragraph (2) to conduct 
inspections shall record in writing their inspection observations and 
shall present the observations to the device establishment's designated 
representative and describe each observation. Additionally, such 
accredited person shall prepare an inspection report

[[Page 116 STAT. 1607]]

(including for inspections classified as `no action indicated') in a 
form and manner consistent with such reports prepared by employees and 
officials designated by the Secretary to conduct inspections.
    ``(B) At a minimum, an inspection report under subparagraph (A) 
shall identify the persons responsible for good manufacturing practice 
compliance at the inspected device establishment, the dates of the 
inspection, the scope of the inspection, and shall describe in detail 
each observation identified by the accredited person, identify other 
matters that relate to or may influence compliance with this Act, and 
describe any recommendations during the inspection or at the 
inspection's closing meeting.
    ``(C) <<NOTE: Deadline.>> An inspection report under subparagraph 
(A) shall be sent to the Secretary and to the designated representative 
of the inspected device establishment at the same time, but under no 
circumstances later than three weeks after the last day of the 
inspection. The report to the Secretary shall be accompanied by all 
written inspection observations previously provided to the designated 
representative of the establishment.

    ``(D) Any statement or representation made by an employee or agent 
of a device establishment to a person accredited under paragraph (2) to 
conduct inspections shall be subject to section 1001 of title 18, United 
States Code.
    ``(E) If at any time during an inspection by an accredited person 
the accredited person discovers a condition that could cause or 
contribute to an unreasonable risk to the public health, the accredited 
person shall immediately notify the Secretary of the identification of 
the device establishment subject to inspection and such condition.
    ``(8) Compensation for an accredited person shall be determined by 
agreement between the accredited person and the person who engages the 
services of the accredited person, and shall be paid by the person who 
engages such services.
    ``(9) Nothing in this subsection affects the authority of the 
Secretary to inspect any device establishment pursuant to this Act.
    ``(10)(A) For fiscal year 2005 and each subsequent fiscal year, no 
device establishment may be inspected during the fiscal year involved by 
a person accredited under paragraph (2) if--
            ``(i) of the amounts appropriated for salaries and expenses 
        of the Food and Drug Administration for the preceding fiscal 
        year (referred to in this subparagraph as the `first prior 
        fiscal year'), the amount obligated by the Secretary for 
        inspections of device establishments by the Secretary was less 
        than the adjusted base amount applicable to such first prior 
        fiscal year; and
            ``(ii) of the amounts appropriated for salaries and expenses 
        of the Food and Drug Administration for the fiscal year 
        preceding the first prior fiscal year (referred to in this 
        subparagraph as the `second prior fiscal year'), the amount 
        obligated by the Secretary for inspections of device 
        establishments by the Secretary was less than the adjusted base 
        amount applicable to such second prior fiscal year.

    ``(B)(i) Subject to clause (ii), the Comptroller General of the 
United States shall determine the amount that was obligated by the 
Secretary for fiscal year 2002 for compliance activities of the Food and 
Drug Administration with respect to devices (referred

[[Page 116 STAT. 1608]]

to in this subparagraph as the `compliance budget'), and of such amount, 
the amount that was obligated for inspections by the Secretary of device 
establishments (referred to in this subparagraph as the `inspection 
budget').
    ``(ii) For purposes of determinations under clause (i), the 
Comptroller General shall not include in the compliance budget or the 
inspection budget any amounts obligated for inspections of device 
establishments conducted as part of the process of reviewing 
applications under section 515.
    ``(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 describing the findings made 
through such determinations.
    ``(C) For purposes of this paragraph:
            ``(i) The term `base amount' means the inspection budget 
        determined under subparagraph (B) for fiscal year 2002.
            ``(ii) The term `adjusted base amount', in the case of 
        applicability to fiscal year 2003, means an amount equal to the 
        base amount increased by 5 percent.
            ``(iii) The term `adjusted base amount', with respect to 
        applicability to fiscal year 2004 or any subsequent fiscal year, 
        means the adjusted based amount applicable to the preceding year 
        increased by 5 percent.

    ``(11) The authority provided by this subsection terminates on 
October 1, 2012.
    ``(12) <<NOTE: Deadline. Reports.>> 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;
            ``(B) the number of persons who sought accreditation under 
        this subsection, as well as the number of persons who were 
        accredited under this subsection;
            ``(C) the reasons why persons who sought accreditation, but 
        were denied accreditation, were denied;
            ``(D) the number of audits conducted by the Secretary of 
        accredited persons, the quality of inspections conducted by 
        accredited persons, whether accredited persons are meeting their 
        obligations under this Act, and whether the number of audits 
        conducted is sufficient to permit these assessments;
            ``(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;
            ``(F) whether this subsection is advancing efforts to allow 
        device establishments to rely upon third-party inspections for 
        purposes of compliance with the laws of foreign governments; and
            ``(G) whether the Congress should continue, modify, or 
        terminate the program under this subsection.

[[Page 116 STAT. 1609]]

    ``(13) The Secretary shall include in the annual report required 
under section 903(g) the names of all accredited persons and the 
particular activities under this subsection for which each such person 
is accredited and the name of each accredited person whose accreditation 
has been withdrawn during the year.
    ``(14) Notwithstanding any provision of this subsection, this 
subsection does not have any legal effect on any agreement described in 
section 803(b) between the Secretary and a foreign country.''.
    (b) Maintenance of Records.--Section 704(f) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 374(f)) is amended--
            (1) in paragraph (1), in the first sentence, by striking ``A 
        person accredited'' and all that follows through ``shall 
        maintain records'' and inserting the following: ``An accredited 
        person described in paragraph (3) shall maintain records'';
            (2) in paragraph (2), by striking ``a person accredited 
        under section 523'' and inserting ``an accredited person 
        described in paragraph (3)''; and
            (3) by adding at the end the following paragraph:

    ``(3) For purposes of paragraphs (1) and (2), an accredited person 
described in this paragraph is a person who--
            ``(A) is accredited under subsection (g); or
            ``(B) is accredited under section 523.''.

    (c) Civil Money Penalty.--Section 303(g)(1)(A) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 333(g)(1)(A)) is amended by adding at 
the end the following: ``For purposes of the preceding sentence, a 
person accredited under paragraph (2) of section 704(g) who is 
substantially not in compliance with the standards of accreditation 
under such section, or who poses a threat to public health or fails to 
act in a manner that is consistent with the purposes of such section, 
shall be considered to have violated a requirement of this Act that 
relates to devices.''.
    (d) Prohibited Acts.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the 
following:
    ``(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.''.
    (e) Conforming Amendment.--Section 510(h) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360(h)) is amended by inserting after ``duly 
designated by the Secretary'' the following: ``, or by persons 
accredited to conduct inspections under section 704(g),''.

SEC. 202. THIRD PARTY REVIEW OF PREMARKET NOTIFICATION.

    Section 523 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360m) is amended--
            (1) in subsection (c), by striking ``The authority'' and all 
        that follows and inserting the following: ``The authority 
        provided by this section terminates October 1, 2007.''; and
            (2) by adding at the end the following subsection:

    ``(d) Report.--Not <<NOTE: Deadline.>> later than January 10, 2007, 
the Secretary shall conduct a study based on the experience under the 
program under this section and submit to the Committee on Energy and

[[Page 116 STAT. 1610]]

Commerce of the House of Representatives, and the Committee on Health, 
Education, Labor, and Pensions of the Senate, a report describing the 
findings of the study. The objectives of the study shall include 
determining--
            ``(1) the number of devices reviewed under this section;
            ``(2) the number of devices reviewed under this section that 
        were ultimately cleared by the Secretary;
            ``(3) the number of devices reviewed under this section that 
        were ultimately not cleared by the Secretary;
            ``(4) the average time period for a review under this 
        section (including the time it takes for the Secretary to review 
        a recommendation of an accredited person under subsection (a) 
        and determine the initial device classification);
            ``(5) the average time period identified in paragraph (4) 
        compared to the average time period for review of devices solely 
        by the Secretary pursuant to section 510(k);
            ``(6) if there is a difference in the average time period 
        under paragraph (4) and the average time period under paragraph 
        (5), the reasons for such difference;
            ``(7) whether the quality of reviews under this section for 
        devices for which no guidance has been issued is qualitatively 
        inferior to reviews by the Secretary for devices for which no 
        guidance has been issued;
            ``(8) whether the quality of reviews under this section of 
        devices for which no guidance has been issued is qualitatively 
        inferior to reviews under this section of devices for which 
        guidance has been issued;
            ``(9) whether this section has in any way jeopardized or 
        improved the public health;
            ``(10) any impact of this section on resources available to 
        the Secretary to review reports under section 510(k); and
            ``(11) any suggestions for continuation, modification 
        (including contraction or expansion of device eligibility), or 
        termination of this section that the Secretary determines to be 
        appropriate.''.

SEC. 203. DEBARMENT OF ACCREDITED PERSONS.

    Section 306 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
335a) is amended by adding at the end the following subsection:
    ``(m) Devices; Mandatory Debarment Regarding Third-Party Inspections 
and Reviews.--
            ``(1) In general.--If the Secretary finds that a person has 
        been convicted of a felony under section 301(gg), the Secretary 
        shall debar such person from being accredited under section 
        523(b) or 704(g)(2) and from carrying out activities under an 
        agreement described in section 803(b).
            ``(2) Debarment period.--The Secretary shall debar a person 
        under paragraph (1) for the following periods:
                    ``(A) The period of debarment of a person (other 
                than an individual) shall not be less than 1 year or 
                more than 10 years, but if an act leading to a 
                subsequent debarment under such paragraph occurs within 
                10 years after such person has been debarred under such 
                paragraph, the period of debarment shall be permanent.
                    ``(B) The debarment of an individual shall be 
                permanent.

[[Page 116 STAT. 1611]]

            ``(3) Termination of debarment; judicial review; other 
        matters.--Subsections (c)(3), (d), (e), (i), (j), and (l)(1) 
        apply with respect to a person (other than an individual) or an 
        individual who is debarred under paragraph (1) to the same 
        extent and in the same manner as such subsections apply with 
        respect to a person who is debarred under subsection (a)(1), or 
        an individual who is debarred under subsection (a)(2), 
        respectively.''.

SEC. 204. DESIGNATION AND REGULATION OF COMBINATION PRODUCTS.

    Section 503(g) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 353(g)) is amended--
            (1) in paragraph (1)--
                    (A) in the first sentence, by striking ``shall 
                designate a component of the Food and Drug 
                Administration'' and inserting ``shall in accordance 
                with this subsection assign an agency center''; and
                    (B) in each of subparagraphs (A) through (C), by 
                striking ``the persons charged'' and inserting ``the 
                agency center charged'';
            (2) by redesignating paragraph (4) as paragraph (5);
            (3) by inserting after paragraph (3) the following 
        paragraph:

    ``(4)(A) <<NOTE: Deadline.>> Not later than 60 days after the date 
of the enactment of this paragraph, the Secretary shall establish within 
the Office of the Commissioner of Food and Drugs an office to ensure the 
prompt assignment of combination products to agency centers, the timely 
and effective premarket review of such products, and consistent and 
appropriate postmarket regulation of like products subject to the same 
statutory requirements to the extent permitted by law. Additionally, the 
office shall, in determining whether a product is to be designated a 
combination product, consult with the component within the Office of the 
Commissioner of Food and Drugs that is responsible for such 
determinations. Such office (referred to in this paragraph as the 
`Office') shall have appropriate scientific and medical expertise, and 
shall be headed by a director.

    ``(B) In carrying out this subsection, the Office shall, for each 
combination product, promptly assign an agency center with primary 
jurisdiction in accordance with paragraph (1) for the premarket review 
of such product.
    ``(C)(i) In carrying out this subsection, the Office shall ensure 
timely and effective premarket reviews by overseeing the timeliness of 
and coordinating reviews involving more than one agency center.
    ``(ii) In order to ensure the timeliness of the premarket review of 
a combination product, the agency center with primary jurisdiction for 
the product, and the consulting agency center, shall be responsible to 
the Office with respect to the timeliness of the premarket review.
    ``(D) In carrying out this subsection, the Office shall ensure the 
consistency and appropriateness of postmarket regulation of like 
products subject to the same statutory requirements to the extent 
permitted by law.
    ``(E)(i) Any dispute regarding the timeliness of the premarket 
review of a combination product may be presented to the Office for 
resolution, unless the dispute is clearly premature.

[[Page 116 STAT. 1612]]

    ``(ii) During the review process, any dispute regarding the 
substance of the premarket review may be presented to the Commissioner 
of Food and Drugs after first being considered by the agency center with 
primary jurisdiction of the premarket review, under the scientific 
dispute resolution procedures for such center. The Commissioner of Food 
and Drugs shall consult with the Director of the Office in resolving the 
substantive dispute.
    ``(F) The Secretary, acting through the Office, shall review each 
agreement, guidance, or practice of the Secretary that is specific to 
the assignment of combination products to agency centers and shall 
determine whether the agreement, guidance, or practice is consistent 
with the requirements of this subsection. In carrying out such review, 
the Secretary shall consult with stakeholders and the directors of the 
agency centers. <<NOTE: Federal Register, publication. Notice.>> After 
such consultation, the Secretary shall determine whether to continue in 
effect, modify, revise, or eliminate such agreement, guidance, or 
practice, and shall publish in the Federal Register a notice of the 
availability of such modified or revised agreement, guidance or 
practice. Nothing in this paragraph shall be construed as preventing the 
Secretary from following each agreement, guidance, or practice until 
continued, modified, revised, or eliminated.

    ``(G) <<NOTE: Deadline. Reports.>> Not later than one year after the 
date of the enactment of this paragraph and annually thereafter, the 
Secretary shall report to the appropriate committees of Congress on the 
activities and impact of the Office. The report shall include 
provisions--
            ``(i) describing the numbers and types of combination 
        products under review and the timeliness in days of such 
        assignments, reviews, and dispute resolutions;
            ``(ii) identifying the number of premarket reviews of such 
        products that involved a consulting agency center; and
            ``(iii) describing improvements in the consistency of 
        postmarket regulation of combination products.

    ``(H) Nothing in this paragraph shall be construed to limit the 
regulatory authority of any agency center.''; and
            (4) in paragraph (5) (as redesignated by paragraph (2) of 
        this section)--
                    (A) by redesignating subparagraphs (A) and (B) as 
                subparagraphs (B) and (C), respectively; and
                    (B) by inserting before subparagraph (B) the 
                following subparagraph:
            ``(A) The term `agency center' means a center or alternative 
        organizational component of the Food and Drug Administration.''.

SEC. 205. <<NOTE: 21 USC 360e note.>> REPORT ON CERTAIN DEVICES.

    Not <<NOTE: Deadline.>> later than one year after the date of 
enactment of this Act, the Secretary of Health and Human Services shall 
report to the appropriate committees of Congress on the timeliness and 
effectiveness of device premarket reviews by centers other than the 
Center for Devices and Radiological Health. Such report shall include 
information on the times required to log in and review original 
submissions and supplements, times required to review manufacturers' 
replies to submissions, and times to approve or clear such devices. Such 
report shall contain the Secretary's recommendations on any measures 
needed to improve performance including, but not limited to, the 
allocation of additional resources.

[[Page 116 STAT. 1613]]

Such report also shall include the Secretary's specific recommendation 
on whether responsibility for regulating such devices should be 
reassigned to those persons within the Food and Drug Administration who 
are primarily charged with regulating other types of devices, and 
whether such a transfer could have a deleterious impact on the public 
health and on the safety of such devices.

SEC. 206. ELECTRONIC LABELING.

    Section 502(f) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 352(f)) is amended by adding at the end the following: ``Required 
labeling for prescription devices intended for use in health care 
facilities may be made available solely by electronic means provided 
that the labeling complies with all applicable requirements of law and, 
that the manufacturer affords health care facilities 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.''.

SEC. 207. ELECTRONIC REGISTRATION.

    Section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360) is amended by adding at the end the following:
    ``(p) Registrations under subsections (b), (c), (d), and (i) 
(including the submission of updated information) shall be submitted to 
the Secretary by electronic means, upon a finding by the Secretary that 
the electronic receipt of such registrations is feasible, unless the 
Secretary grants a request for waiver of such requirement because use of 
electronic means is not reasonable for the person requesting such 
waiver.''.

SEC. 208. INTENDED USE.

    Section 513(i)(1)(E) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360c(i)(1)(E)) is amended by striking clause (iv).

SEC. 209. MODULAR REVIEW.

    Section 515(c) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360e(c)) is amended by adding at the end the following:
    ``(3)(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 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.''.

[[Page 116 STAT. 1614]]

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 at the end the following: ``Where 
appropriate, the Secretary shall ensure that such panel includes, or 
consults with, one or more pediatric experts.''.

SEC. 211. INTERNET LIST OF CLASS II DEVICES EXEMPTED FROM REQUIREMENT OF 
            PREMARKET NOTIFICATION.

    Section 510(m)(1) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360(m)(1)) is amended by adding at the end the following: ``The 
Secretary shall publish such list on the Internet site of the Food and 
Drug Administration. The list so published shall be updated not later 
than 30 days after each revision of the list by the Secretary.''.

SEC. 212. <<NOTE: 21 USC 360l note.>> STUDY BY INSTITUTE OF MEDICINE OF 
            POSTMARKET SURVEILLANCE REGARDING PEDIATRIC POPULATIONS.

    (a) In General.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary'') shall request the 
Institute of Medicine to enter into an agreement with the Secretary 
under which such Institute conducts a study for the purpose of 
determining whether the system under the Federal Food, Drug, and 
Cosmetic Act for the postmarket surveillance of medical devices provides 
adequate safeguards regarding the use of devices in pediatric 
populations.
    (b) Certain Matters.--The Secretary shall ensure that determinations 
made in the study under subsection (a) include determinations of--
            (1) whether postmarket surveillance studies of implanted 
        medical devices are of long enough duration to evaluate the 
        impact of growth and development for the number of years that 
        the child will have the implant, and whether the studies are 
        adequate to evaluate how children's active lifestyles may affect 
        the failure rate and longevity of the implant; and
            (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.

    (c) Report to Congress.--The <<NOTE: Deadline.>> Secretary shall 
ensure that, not later than four years after the date of the enactment 
of this Act, a report describing the findings of the study under 
subsection (a) is submitted to the Congress. The report shall include 
any recommendations of the Secretary for administrative or legislative 
changes to the system of postmarket surveillance referred to in such 
subsection.

SEC. 213. <<NOTE: 21 USC 360j note.>> GUIDANCE REGARDING PEDIATRIC 
            DEVICES.

    Not <<NOTE: Deadline.>> later than 270 days after the date of the 
enactment of this Act, the Secretary of Health and Human Services shall 
issue guidance on the following:

[[Page 116 STAT. 1615]]

            (1) The type of information necessary to provide reasonable 
        assurance of the safety and effectiveness of medical devices 
        intended for use in pediatric populations.
            (2) Protections for pediatric subjects in clinical 
        investigations of the safety or effectiveness of such devices.

SEC. 214. <<NOTE: 42 USC 289g-3 note.>> BREAST IMPLANTS; STUDY BY 
            COMPTROLLER GENERAL.

    (a) In General.--The Comptroller General of the United States shall 
conduct a study to determine the following with respect to breast 
implants:
            (1) The content of information typically provided by health 
        professionals to women who consult with such professionals on 
        the issue of whether to undergo breast implant surgery.
            (2) Whether such information is provided by physicians or 
        other health professionals, and whether the information is 
        provided verbally or in writing, and at what point in the 
        process of determining whether to undergo surgery is such 
        information provided.
            (3) Whether the information presented, as a whole, provides 
        a complete and accurate discussion of the risks and benefits of 
        breast implants, and the extent to which women who receive such 
        information understand the risks and benefits.
            (4) The number of adverse events that have been reported, 
        and whether such events have been adequately investigated.
            (5) With respect to women who participate as subjects in 
        research being carried out regarding the safety and 
        effectiveness of breast implants:
                    (A) The content of information provided to the women 
                during the process of obtaining the informed consent of 
                the women to be subjects, and the extent to which such 
                information is updated.
                    (B) Whether such process provides written 
                explanations of the criteria for being subjects in the 
                research.
                    (C) The point at which, in the planning or conduct 
                of the research, the women are provided information 
                regarding the provision of informed consent to be 
                subjects.

    (b) Report.--The Comptroller General shall submit to the Congress a 
report describing the findings of the study.
    (c) Definition.--For purposes of this section, the term ``breast 
implant'' means a breast prosthesis that is implanted to augment or 
reconstruct the female breast.

SEC. 215. BREAST IMPLANTS; RESEARCH THROUGH NATIONAL INSTITUTES OF 
            HEALTH.

    (a) Report on Status of Current Research.--
Not <<NOTE: Deadline. Reports.>> later than 180 days after the date of 
the enactment of this Act, the Director of the National Institutes of 
Health shall submit to the Congress a report describing the status of 
research on breast implants (as defined in section 213(c)) being 
conducted or supported by such Institutes.

    (b) Research on Long-Term Implications.--Part H of title IV of the 
Public Health Service Act (42 U.S.C. 289 et seq.) is amended by adding 
at the end of the following section:

``SEC. 498C. <<NOTE: 42 USC 289g-3.>> BREAST IMPLANT RESEARCH.

    ``(a) In General.--The Director of NIH may conduct or support 
research to examine the long-term health implications of silicone

[[Page 116 STAT. 1616]]

breast implants, both gel and saline filled. Such research studies may 
include the following:
            ``(1) Developing and examining techniques to measure 
        concentrations of silicone in body fluids and tissues.
            ``(2) Surveillance of recipients of silicone breast 
        implants, including long-term outcomes and local complications.

    ``(b) Definition.--For purposes of this section, the term `breast 
implant' means a breast prosthesis that is implanted to augment or 
reconstruct the female breast.''.

                    TITLE III--ADDITIONAL AMENDMENTS

SEC. 301. IDENTIFICATION OF MANUFACTURER OF MEDICAL DEVICES.

    (a) In General.--Section 502 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 352) is amended by adding at the end the following:
    ``(u) If it is a device, unless it, or an attachment thereto, 
prominently and conspicuously bears the name of the manufacturer of the 
device, a generally recognized abbreviation of such name, or a unique 
and generally recognized symbol identifying such manufacturer, except 
that the Secretary may waive any requirement under this paragraph for 
the device if the Secretary determines that compliance with the 
requirement is not feasible for the device or would compromise the 
provision of reasonable assurance of the safety or effectiveness of the 
device.''.
    (b) Effective Date.--The <<NOTE: 21 USC 352 note.>> amendment made 
by subsection (a) takes effect 18 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.

SEC. 302. SINGLE-USE MEDICAL DEVICES.

    (a) Required Statements on Labeling.--
            (1) In general.--Section 502 of the Federal Food, Drug, and 
        Cosmetic Act, as amended by section 301 of this Act, is amended 
        by adding at the end the following:

    ``(v) If it is a reprocessed single-use device, unless all labeling 
of the device prominently and conspicuously bears the statement 
`Reprocessed device for single use. Reprocessed by ____.' The name of 
the manufacturer of the reprocessed device shall be placed in the space 
identifying the person responsible for reprocessing.''.
            (2) Effective date.--The amendment made by paragraph (1) 
        takes effect 15 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.

    (b) Premarket Notification.--Section <<NOTE: 21 USC 352 note.>> 510 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360) is amended 
by inserting after subsection (n) the following:

    ``(o)(1) With respect to reprocessed single-use devices for which 
reports are required under subsection (k):
            ``(A) The Secretary shall identify such devices or types of 
        devices for which reports under such subsection must, in order 
        to ensure that the device is substantially equivalent to a 
        predicate device, include validation data, the types of which 
        shall be specified by the Secretary, regarding cleaning and 
        sterilization, and functional performance demonstrating

[[Page 116 STAT. 1617]]

        that the single-use device will remain substantially equivalent 
        to its predicate device after the maximum number of times the 
        device is reprocessed as intended by the person submitting the 
        premarket notification. <<NOTE: Federal Register, 
        publication.>> Within six months after enactment of this 
        subsection, the Secretary shall publish in the Federal Register 
        a list of the types so identified, and shall revise the list as 
        appropriate. Reports under subsection (k) for devices or types 
        of devices within a type included on the list are, upon 
        publication of the list, required to include such validation 
        data.
            ``(B) <<NOTE: Deadline.>> 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 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.
            ``(C) In the case of a report under subsection (k) for a 
        device identified under subparagraph (A) that is of a type for 
        which the Secretary has not previously received a report under 
        such subsection, the Secretary may, in advance of revising the 
        list under subparagraph (A) to include such type, require that 
        the report include the validation data specified in subparagraph 
        (A).
            ``(D) Section 502(o) applies with respect to the failure of 
        a report under subsection (k) to include validation data 
        required under subparagraph (A).

    ``(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) The Secretary shall identify such devices or types of 
        devices for which such exemptions should be terminated in order 
        to provide a reasonable assurance of the safety and 
        effectiveness of the devices. <<NOTE: Federal Register, 
        publication.>> The Secretary shall publish in the Federal 
        Register a list of the devices or types of devices so 
        identified, and shall revise the list as appropriate. The 
        exemption for each device or type included on the list is 
        terminated upon the publication of the list. For each report 
        under subsection (k) submitted pursuant to this subparagraph the 
        Secretary shall require the validation data described in 
        paragraph (1)(A).

[[Page 116 STAT. 1618]]

            ``(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 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.
            ``(C) <<NOTE: Deadlines.>> In the case of semi-critical 
        devices, the initial list under subparagraph (A) shall be 
        published not later than 18 months after the effective date of 
        this subsection. In the case of critical devices, the initial 
        list under such subparagraph shall be published not later than 
        six months after such effective date.
            ``(D) Section 502(o) applies with respect to the failure to 
        submit a report under subsection (k) that is required pursuant 
        to subparagraph (A), including a failure of the report to 
        include validation data required in such subparagraph.
            ``(E) The termination under subparagraph (A) of an exemption 
        under subsection (l) or (m) for a critical or semicritical 
        reprocessed single-use device does not terminate the exemption 
        under subsection (l) or (m) for the original device.''.

    (c) Premarket Report.--Section 515 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360e) is amended--
            (1) in subsection (a), in the matter after and below 
        paragraph (2), by inserting before the period the following: 
        ``or, as applicable, an approval under subsection (c)(2) of a 
        report seeking premarket approval''; and
            (2) in subsection (c)--
                    (A) by redesignating paragraph (2) as paragraph (3); 
                and
                    (B) by inserting after paragraph (1) the following 
                paragraph:

    ``(2)(A) Any person may file with the Secretary a report seeking 
premarket approval for a class III device referred to in subsection (a) 
that is a reprocessed single-use device. Such a report shall contain the 
following:
            ``(i) The device name, including both the trade or 
        proprietary name and the common or usual name.
            ``(ii) The establishment registration number of the owner or 
        operator submitting the report.
            ``(iii) Actions taken to comply with performance standards 
        under section 514.

[[Page 116 STAT. 1619]]

            ``(iv) Proposed labels, labeling, and advertising sufficient 
        to describe the device, its intended use, and directions for 
        use.
            ``(v) Full reports of all information, published or known to 
        or which should be reasonably known to the applicant, concerning 
        investigations which have been made to show whether or not the 
        device is safe or effective.
            ``(vi) A description of the device's components, 
        ingredients, and properties.
            ``(vii) A full description of the methods used in, and the 
        facilities and controls used for, the reprocessing and packing 
        of the device.
            ``(viii) Such samples of the device that the Secretary may 
        reasonably require.
            ``(ix) A financial certification or disclosure statement or 
        both, as required by part 54 of title 21, Code of Federal 
        Regulations.
            ``(x) A statement that the applicant believes to the best of 
        the applicant's knowledge that all data and information 
        submitted to the Secretary are truthful and accurate and that no 
        material fact has been omitted in the report.
            ``(xi) Any additional data and information, including 
        information of the type required in paragraph (1) for an 
        application under such paragraph, that the Secretary determines 
        is necessary to determine whether there is reasonable assurance 
        of safety and effectiveness for the reprocessed device.
            ``(xii) Validation data described in section 510(o)(1)(A) 
        that demonstrates that the reasonable assurance of the safety or 
        effectiveness of the device will remain after the maximum number 
        of times the device is reprocessed as intended by the person 
        submitting such report.

    ``(B) In the case of a class III device referred to in subsection 
(a) that is a reprocessed single-use device:
            ``(i) Subparagraph (A) of this paragraph applies in lieu of 
        paragraph (1).
            ``(ii) Subject to clause (i), the provisions of this section 
        apply to a report under subparagraph (A) to the same extent and 
        in the same manner as such provisions apply to an application 
        under paragraph (1).
            ``(iii) Each reference in other sections of this Act to an 
        application under this section, other than such a reference in 
        section 737 or 738, shall be considered to be a reference to a 
        report under subparagraph (A).
            ``(iv) Each reference in other sections of this Act to a 
        device for which an application under this section has been 
        approved, or has been denied, suspended, or withdrawn, other 
        than such a reference in section 737 or 738, shall be considered 
        to be a reference to a device for which a report under 
        subparagraph (A) has been approved, or has been denied, 
        suspended, or withdrawn, respectively.''.

    (d) Definitions.--Section 201 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the 
following:
    ``(ll)(1) The term `single-use device' means a device that is 
intended for one use, or on a single patient during a single procedure.

[[Page 116 STAT. 1620]]

    ``(2)(A) The term `reprocessed', with respect to a single-use 
device, means an original device that has previously been used on a 
patient and has been subjected to additional processing and 
manufacturing for the purpose of an additional single use on a patient. 
The subsequent processing and manufacture of a reprocessed single-use 
device shall result in a device that is reprocessed within the meaning 
of this definition.
    ``(B) A single-use device that meets the definition under clause (A) 
shall be considered a reprocessed device without regard to any 
description of the device used by the manufacturer of the device or 
other persons, including a description that uses the term `recycled' 
rather than the term `reprocessed'.
    ``(3) The term `original device' means a new, unused single-use 
device.
    ``(mm)(1) The term `critical reprocessed single-use device' means a 
reprocessed single-use device that is intended to contact normally 
sterile tissue or body spaces during use.
    ``(2) The term `semi-critical reprocessed single-use device' means a 
reprocessed single-use device that is intended to contact intact mucous 
membranes and not penetrate normally sterile areas of the body.''.

SEC. 303. MEDWATCH.

    Not later <<NOTE: Deadline.>> than 6 months after the date of the 
enactment of this Act, the Secretary of Health and Human Services shall 
modify the MedWatch mandatory and voluntary forms to facilitate the 
reporting of information by user facilities or distributors as 
appropriate relating to reprocessed single-use devices, including the 
name of the reprocessor and whether the device has been reused.

    Approved October 26, 2002.

LEGISLATIVE HISTORY--H.R. 5651:
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CONGRESSIONAL RECORD, Vol. 148 (2002):
            Oct. 16, considered and passed House.
            Oct. 17, considered and passed Senate.
WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 38 (2002):
            Oct. 26, 28, Presidential remarks and statement.

                                  <all>
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