[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5651 Engrossed in House (EH)]

  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
107th CONGRESS
  2d Session
                                H. R. 5651

_______________________________________________________________________

                                 AN ACT


 
To amend the Federal Food, Drug, and Cosmetic Act to make improvements 
     in the regulation of medical devices, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This 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.

                TITLE I--FEES RELATED TO MEDICAL DEVICES

SEC. 101. 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. 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 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.
                    ``(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. 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.
                            ``(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 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 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 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. 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 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), 
        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 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 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 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) 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 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 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) 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 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.
    ``(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 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 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 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 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. 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) 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, 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) 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 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. 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 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.

SEC. 106. 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. 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) 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) 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.
            ``(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) 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 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.
    ``(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) 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.
            ``(II) In the case of an inspection to be conducted 
        pursuant to 510(i), the Secretary periodically conducts 
        inspections of the establishment.
    ``(B)(i) 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) 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 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. 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 (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) 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 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) 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.
    ``(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 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 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.
            ``(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) 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.
    ``(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. 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) 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. REPORT ON CERTAIN DEVICES.

    Not 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. 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.''.

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. 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 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. GUIDANCE REGARDING PEDIATRIC DEVICES.

    Not 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:
            (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. 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 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. BREAST IMPLANT RESEARCH.

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

            Passed the House of Representatives October 16, 2002.

            Attest:

                                                                 Clerk.
107th CONGRESS

  2d Session

                               H. R. 5651

_______________________________________________________________________

                                 AN ACT

To amend the Federal Food, Drug, and Cosmetic Act to make improvements 
     in the regulation of medical devices, and for other purposes.