[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5651 Enrolled Bill (ENR)]

        H.R.5651

                      One Hundred Seventh Congress

                                 of the

                        United States of America


                          AT THE SECOND SESSION

         Begun and held at the City of Washington on Wednesday,
          the twenty-third day of January, two thousand and two


                                 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.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.