[Congressional Record (Bound Edition), Volume 148 (2002), Part 14]
[House]
[Pages 19392-19404]
[From the U.S. Government Publishing Office, www.gpo.gov]




         MEDICAL DEVICE USER FEE AND MODERNIZATION ACT OF 2002

  Mr. BURR of North Carolina. Mr. Speaker, I move to suspend the rules 
and pass the bill (H.R. 3580) to amend the Federal Food, Drug, and 
Cosmetic Act to make improvements in the regulation of medical devices, 
and for other purposes.
  The Clerk read as follows:

                               H.R. 3580

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

                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 furnishing 
     additional funds for the review of devices so that 
     statutorily mandated deadlines may be met; and
       (3) the fees authorized by the amendment made by section 
     102 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.

     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

[[Page 19393]]

       ``(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 510(o)(3).
       ``(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 has been approved under section 515(d) 
     or 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 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 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 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 1.75 percent of the fee that applies under clause 
     (i), subject to any adjustment under subsection (c)(3).
       ``(B) Exceptions.--
       ``(i) Humanitarian device exemption.--A device for which a 
     humanitarian device exemption has been granted is not subject 
     to the fees established in 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 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 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

[[Page 19394]]

     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), (f), and (g), 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 this Act 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). Only fees for 180 day supplements and 
     premarket notification submissions shall be increased to 
     generate compensating adjustment revenues.
       ``(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, except that the 
     fees established for fiscal year 2003 shall be based on a 
     premarket application fee of $139,000.
       ``(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 Business Fee Waiver and Fee Reduction.--
       ``(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 small businesses.--
       ``(A) Definition.--
       ``(i) For purposes of this subsection, the term `small 
     business' means an entity that reported $10,000,000 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, or parent firms.
       ``(ii) The Secretary may adjust the $10,000,000 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 13 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, which shows an amount of gross 
     sales or receipts that is less than the maximum established 
     in subparagraph (A). The applicant shall certify that the 
     information provided is a true and accurate copy of the 
     applicant's actual tax forms as submitted to the Internal 
     Revenue Service.
       ``(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 reduced rates as follows:
       ``(i) 38 percent of the fee established under subsection 
     (c)(5) for a premarket application, a premarket report, a 
     panel-track supplement, or an efficacy supplement.
       ``(ii) 44 percent of the fee established under subsection 
     (c)(5) for a 180-day supplement to a medical device 
     application.
       ``(iii) 25 percent of the fee established under subsection 
     (c)(5) for a real-time supplement to a premarket application.
     This subsection may not be construed as authorizing any 
     reduction in the fee established under subsection (c)(5) for 
     a premarket notification submission.
       ``(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).
       ``(e) 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.
       ``(f) 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 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.

[[Page 19395]]

       ``(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.
       ``(g) 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.
       ``(h) 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.
       ``(i) 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.
       ``(j) 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

[[Page 19396]]

     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 who are 
     not Federal employees for the purpose of conducting the 
     inspections required in section 510(h), or pursuant to 
     section 510(i), for establishments that manufacture, prepare, 
     propagate, compound, or process class II or class III 
     devices. 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 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 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.
       ``(B) Such person shall be a legally constituted entity 
     permitted to conduct the activities for which it seeks 
     accreditation.
       ``(C) Such person shall not engage in the design, 
     manufacture, promotion, or sale of articles regulated under 
     this Act.
       ``(D) 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;
       ``(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;
       ``(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 accredited persons 
     to conduct inspections under paragraph (1). Such list shall 
     be periodically updated to ensure that the identity of each 
     accredited person 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 
     withdrawal of accreditation.
       ``(5)(A) To ensure that persons accredited under this 
     subsection continue to meet the standards of accreditation, 
     the Secretary shall 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 an establishment and the 
     performance of accredited persons.
       ``(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) through (C), a device 
     establishment is eligible for inspections by persons 
     accredited under paragraph (2) if--
       ``(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'; and
       ``(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.
       ``(B)(i) The Secretary shall respond to a notice under 
     subparagraph (A) from an 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 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.
     The Secretary may make both such requests.
       ``(iii) The compliance data to be submitted by an 
     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 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 an establishment, the Secretary 
     shall provide or deny clearance under subparagraph (A). The 
     Secretary may not deny clearance unless the Secretary 
     provides to the establishment detailed findings that the 
     establishment has failed to demonstrate consistent compliance 
     for purposes of clause (iii). If the Secretary fails to 
     provide such findings 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 
     establishment involved. The Secretary may not reject the 
     selection unless the Secretary provides to the establishment 
     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. 
     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 an 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).

[[Page 19397]]

       ``(vi) In the case of an 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 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 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 a detailed reason 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 discuss 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 
     establishment involved, the dates of the inspection, the 
     scope of the inspection, and shall discuss in detail each 
     observation identified by the accredited person, identify 
     other matters that relate to or may influence compliance with 
     this Act, and discuss 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 the designated representative of 
     the inspected establishment involved 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 representative of the establishment.
       ``(D) Any statements or representations made by employees 
     or agents of a device establishment to persons 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 facility subject to 
     inspection and the conditions of concern.
       ``(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 establishments pursuant to this Act.
       ``(10)(A) For fiscal year 2005 and subsequent fiscal years, 
     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 conducted by accredited 
     persons and the number of inspections pursuant to subsections 
     (h) and (i) of section 510 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 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.''.
       (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) 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;

[[Page 19398]]

       ``(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 expansion of device eligibility), or termination 
     of this section that the Secretary determines to be 
     appropriate.''.

     SEC. 203. 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 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) In carrying out this subsection, the Office shall 
     ensure timely and effective premarket reviews by overseeing 
     and coordinating reviews involving more than one agency 
     center.
       ``(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. Nothing in this 
     paragraph shall be construed to limit the postmarket 
     regulatory authority of any agency center.
       ``(E) 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.
       ``(F)(i) Any dispute regarding the timeliness of the 
     premarket review of a combination product may be presented to 
     the Office for resolution, unless the timeliness of 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.
       ``(G) 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.
       ``(H) 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.''; 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. 204. 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. 205. 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. 206. 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. 207. 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. 208. 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 
     portions of such applications that applicants and the 
     Secretary agree are complete, ready, and appropriate for 
     review.
       ``(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 issues of 
     safety or effectiveness provide the Secretary cause to review 
     such accepted portion.
       ``(C) Whenever the Secretary determines that a portion of a 
     submission under subparagraph (A) is unacceptable, the 
     Secretary shall specifically identify, in writing, the 
     deficiency of such portion and describe in detail the means 
     by which it may be made acceptable, unless the sponsor is no 
     longer pursuing the application.''.

     SEC. 209. PEDIATRIC EXPERTISE REGARDING CLASSIFICATION-PANEL 
                   REVIEW OF PREMARKET APPLICATIONS.

       Section 515(c)(2) of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 360e(c)(2)) is amended by adding at the end 
     the following: ``If the Secretary determines that there is a 
     reasonable likelihood that the device involved will be used 
     in a pediatric population, the Secretary shall ensure that 
     such panel includes, or consults with, one or more pediatric 
     experts.''.

     SEC. 210. 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

[[Page 19399]]

     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. 211. 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 amount of funds allocated for 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. 212. GUIDANCE REGARDING PEDIATRIC DEVICES.

       Section 520 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360j) is amended by adding at the end the following 
     subsection:

                 ``Guidance Regarding Pediatric Devices

       ``(n) Not later than 270 days after the date of the 
     enactment of the Medical Device User Fee and Modernization 
     Act of 2002, the Secretary shall issue guidance on the 
     following:
       ``(1) The type of information necessary to provide 
     reasonable assurance of the safety and effectiveness of 
     devices intended for use in pediatric populations.
       ``(2) Protections for pediatric subjects in clinical 
     investigations of the safety or effectiveness of such 
     devices.''.

     SEC. 213. 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.
       (3) Whether the information provided presents a fair and 
     balanced statement of the risks and benefits of receiving the 
     implants (taking into account the frequency of updates to the 
     information), and if so, at what point in the process of 
     determining whether to undergo surgery is such information 
     provided.
       (4) Whether women understand the information that is 
     provided (including full appreciation of the risks), and 
     whether and to what extent the information influences the 
     decision to receive the implants.
       (5) The number of adverse events that have been reported, 
     and whether such events have been adequately investigated.
       (6) 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 whether such information is appropriately 
     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.
       (D) Whether, before providing informed consent, the women 
     fully appreciate the risks of being subjects in the research.
       (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. 214. 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 shall conduct or 
     support prospective or retrospective research to examine the 
     long-term health implications of both saline and silicone 
     breast implants. If scientifically appropriate, such research 
     studies may include the following:
       ``(1) A multidisciplinary study of women who have received 
     silicone and saline implants and have had an implant for a 
     sufficient amount of time to allow for appropriate comparison 
     as to the long-term health consequences.
       ``(2) A comparison of women receiving implants for 
     reconstruction after mastectomy to breast cancer patients who 
     have not had reconstruction, including subsets of women with 
     saline implants and women with silicone implants.
       ``(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 one year 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)

[[Page 19400]]

     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 semicritical 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) The initial list under subparagraph (A) shall be 
     published not later than 18 months after the effective date 
     of this subsection.
       ``(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.
       ``(3) In the case of a reprocessed single-use device that 
     is classified in class III and for which a premarket 
     application is required, the following provisions apply with 
     respect to such reprocessed device in lieu of an application 
     for premarket approval under section 515:
       ``(A) The device shall not be introduced into interstate 
     commerce or delivered for introduction into interstate 
     commerce unless the person involved has submitted to the 
     Secretary a report in accordance with this paragraph and the 
     Secretary, after reviewing the report, issues an order 
     determining there is a reasonable assurance of the safety and 
     effectiveness for the device.
       ``(B) The report under subparagraph (A) 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 a 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 that the 
     Secretary determines is necessary to determine whether there 
     is reasonable assurance of safety and effectiveness for the 
     reprocessed device.
       ``(C) In addition to the information or data required in 
     subparagraph (B), the report under subparagraph (A) shall 
     include the validation data described in paragraph (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 the report under this paragraph.''.
       (c) 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 
     subparagraph (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.''.
       (d) Prohibited Acts.--Section 301 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 331), as amended by section 
     321(b)(2) of Public Law 107-188, is amended by adding at the 
     end the following:
       ``(gg) The introduction or delivery for introduction into 
     interstate commerce of any device in violation of section 
     510(o)(3).''.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
North Carolina (Mr. Burr) and the gentleman from Ohio (Mr. Brown) each 
will control 20 minutes.
  The Chair recognizes the gentleman from North Carolina (Mr. Burr).


                             General Leave

  Mr. BURR of North Carolina. Mr. Speaker, I ask unanimous consent that 
all Members may have 5 legislative days within which to revise and 
extend their remarks and include extraneous material on this 
legislation, H.R. 3580.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from North Carolina?
  There was no objection.
  Mr. BURR of North Carolina. Mr. Speaker, I yield myself such time as 
I may consume.
  Mr. Speaker, I rise today in strong support of H.R. 3580, the Medical 
Device User Fee and Modernization Act. This bill represents a 
bipartisan agreement reached after months of negotiation. I commend the 
sponsors of this legislation, the gentleman from Pennsylvania (Mr. 
Greenwood) and the gentlewoman from California (Ms. Eshoo), as well as 
the gentleman from Louisiana (Mr. Tauzin), the gentleman from Florida 
(Mr. Bilirakis), the gentleman from Michigan (Mr. Dingell), the 
gentleman from Ohio (Mr. Brown), and the gentleman from California (Mr. 
Waxman) for their efforts in reaching an agreement on this very 
important legislation.
  Further, I would like to thank our highly skilled legislative 
counsel, Pete Goodloe, for his tireless work in drafting this bill.
  The medical device industry is one of the most innovative industries 
regulated by the Food and Drug Administration. Whereas other regulated 
industries have products with life cycles measured in decades, the life 
cycles for medical devices are measured, in many cases, in months. In 
this industry, the rule is simply innovate or die.
  When an industry is innovative, we need to ensure that their devices 
receive an efficient review by the Food and Drug Administration. The 
best ways we can help is to provide the agency with more resources. 
This bill will do just that, by providing the FDA with more than $200 
million over the next 5 years. With this new money, the agency will be 
able to hire more reviewers and update information on technology.
  The user fee approach used in this bill is similar to the initial 
version of the very successful Prescription Drug User Fee Act. Under 
this proposal, the

[[Page 19401]]

industry will pay application fees to the FDA in exchange for the FDA's 
promise to meet performance goals. We have also built in protections 
for smaller businesses, exempting many from fees for their first pre-
market application.
  Also included in the bill are needed regulatory reforms, the most 
important of which is the creation of a third-party inspection. Under 
third-party inspection, companies with good inspection records will be 
able to select an independent FDA-accredited third party to perform 
their FDA inspection. This will provide FDA with more inspectional 
information. Further, by adopting this approach, we empower companies 
to schedule their various international inspections along with their 
FDA inspections. By allowing third-party inspections, we are sending a 
signal to the rest of the world that they are an acceptable 
alternative, hopefully leading to a more mutual recognition. 
Importantly, this provision also requires FDA to maintain their current 
level of effort for FDA inspections.
  Finally, this bill includes medical device processing reforms which 
ensure that device end-users always know if the devices they use have 
been reprocessed. Let me be perfectly clear. There is absolutely no 
hard evidence that reprocessing devices are unsafe or ineffective. 
Nonetheless, because these devices can be different than original 
devices, we empower the FDA to collect better data. It is good policy, 
good public policy; and it deserves the support of this House, just as 
it has the support of the affected manufacturers and the hospitals.
  Again, I would urge my colleagues to offer a strong ``yea'' vote in 
favor of this bipartisan legislation. The spirit of this bill reflects 
the House at its finest.
  Mr. Speaker, I reserve the balance of my time.
  Mr. BROWN of Ohio. Mr. Speaker, I yield myself such time as I may 
consume.
  Mr. Speaker, the medical device legislation we are considering today 
is the product of lengthy, bipartisan negotiations. It is a good 
compromise bill. I appreciate the majority's willingness to work with 
us to ensure the legislation promotes timely access to medical devices 
without compromising FDA's ability to do its job, that is, to ensure 
medical products, both drugs and devices, are safe and effective for 
their intended uses and to make sure these products are promoted to the 
medical community and to the public in an accurate manner, and for the 
benefit of the FDA's general counsel, who has repeatedly questioned 
FDA's authority to regulate the advertising associated with drugs and 
devices. When I say promoted in an accurate manner, I mean accurate 
labeling and accurate balanced advertising. After all, a product is no 
longer safe and effective if it is being marketed as something it is 
not.
  I mentioned Dan Troy, who is not unlike other Bush appointees to FDA, 
HHS, OMB, former drug company employees, people like Ann Marie Lynch, 
who was with PhRMA and now is a deputy assistant of HHS; Mitch Daniels, 
in the cabinet, OMB, a former executive with Eli Lilly; Linda Skladany, 
a deputy commissioner for the Food and Drug Administration; all people 
from PhRMA, all people from the big drug industry who are positioned 
throughout this administration, unfortunately making drug policy and, 
frankly, turning the FDA into a little bit too cozy an agency in its 
relationship with drug companies when it is supposed to be protecting 
the public interests.

                              {time}  2145

  But that is a story and a battle for another day.
  I want to thank the gentleman from Louisiana (Chairman Tauzin); the 
gentleman from Florida (Chairman Bilirakis); the ranking member, the 
gentleman from Michigan (Mr. Dingell); the gentleman from Pennsylvania 
(Mr. Greenwood); and my friend, the gentlewoman from California (Ms. 
Eshoo); for their work on this bill and extend a special thanks to 
Brent Delmonte and Steve Tilton with the majority and John Ford and 
David Nelson on our staff.
  It is clearly in the public's interest for Congress to promote timely 
access to safe and effective medical devices. This bill advances that 
goal. This legislation establishes a user fee to provide FDA added 
funds for the review of medical devices.
  It is no secret that resource shortfalls have hindered the review 
process in the past, and additional resources are crucial to ensure the 
timeliness and quality of device reviews. However, as we learned in the 
Prescription Drug User Fee Act, it is crucial to couple expedited 
review of new medical products with effective postmarket surveillance 
of these products.
  When we speed up approval of medical products, be they prescription 
drugs or medical devices, we owe it to the people of the country, the 
users of these products, the medical devices and the prescription 
drugs, to make sure these products are watched for safety and 
effectiveness problems after approval.
  Again, under the Bush administration, under Republican control of 
FDA, we have seen an agency that has gotten cozier with the industry, 
from its statements to our committee, from its public statements and, 
most importantly, from the appointees to that agency from the industry. 
It is particularly important we have this postmarket surveillance so we 
can see how these drugs and medical devices operate once in the general 
population.
  While I believe a portion of the device user fees should be used to 
support postmarket surveillance activities, I appreciate the majority's 
willingness to try to accommodate the underlying concern by 
establishing an increased authorization specifically for postmarket 
surveillance activities.
  This legislation initiates third-party inspection of medical device 
facilities. Allowing device manufacturers to pay private parties to 
carry out required inspections of their plants, rather than be 
inspected by the FDA, is controversial. Like the user fee program, it 
raises, again, with an FDA that is a little bit too cozy with industry, 
it raises significant conflict of interest issues.
  Ideally, FDA would be given sufficient resources to carry out its 
review and inspection responsibilities without needing to rely on 
either user fees or delegation of its responsibilities to private 
parties.
  I recognize, however, that FDA has not received sufficient resources 
to carry out all their responsibilities that we have given it. In the 
absence of adequate appropriations, the agency is not conducting 
required inspections in a timely manner, nor meeting statutory deadline 
lines for some device reviews.
  Given this reality, it is appropriate to explore alternatives. While 
Congress and FDA will need to carefully monitor the user fee and third-
party inspection programs to ensure that the public is being well 
served by them, it makes sense to give these programs a chance.
  I urge my colleagues' support for the bill.
  Madam Speaker, I reserve the balance of my time.
  Mr. BURR of North Carolina. Madam Speaker, I yield myself such time 
as I may consume.
  Madam Speaker, I appreciate the remarks from the gentleman from Ohio 
(Mr. Brown). I think that, clearly, there will be a continuing debate 
in Washington around whether we fund agencies at an adequate level. The 
reality is that agencies have the determination to decide where they 
put their funding, and in many cases it is our responsibility to make 
sure that we bring them back focused on their core mission. In the case 
of the FDA, it is on food safety, it is on the approval of 
pharmaceutical applications, and it is on the approval of medical 
devices. I think we enhance that likelihood with the passage of this 
bill.
  Madam Speaker, I reserve the balance of my time.
  Mr. BROWN of Ohio. Madam Speaker, I yield 5 minutes to the 
gentlewoman from California (Ms. Eshoo).
  Ms. ESHOO. Madam Speaker, I thank our ranking member of the 
Subcommittee on Health for yielding time to me.
  Madam Speaker, I am so pleased, I am really very excited, that the 
House is considering this evening H.R. 3580,

[[Page 19402]]

legislation which I introduced with my wonderful colleague, the 
gentleman from Pennsylvania (Mr. Greenwood), and worked with so many 
others on.
  It has been over a long period of time, not a short period of time, 
so I think that is why we are very excited that we have finally made it 
to the floor in the culmination of our work. It is a bipartisan bill, 
and it really is ultimately about patients, patients in our country, 
about making sure that patients are able to safely benefit from the 
wonders of medical technology in a very timely manner.
  As medical technologies have become more advanced, it takes more 
government resources to ensure that these products are safe and 
effective. That falls to a Federal agency, and that is the Food and 
Drug Administration. They regulate medical devices, and they have been 
overwhelmed by the volume of new products that they must review.
  So, number one, under this bill, and for the very first time in the 
history of our country, the medical device industry has agreed and will 
pay fees to the FDA for every product they propose to market. It is a 
very important change, something that was fought several years ago, but 
the industry has now moved to this position, and I think that it is a 
wise one. The fees will help the FDA hire additional staff and purchase 
needed equipment so that they can review the products on a timely 
basis.
  Number two, the bill also increases resources for additional 
inspections of manufacturing plants and facilities.
  I would just like to take a moment to say to my distinguished 
colleague, the gentleman from Ohio, that in terms of third-party 
inspections, these are not private sector people that companies just go 
out and choose; in other words, put the fox in charge of the chicken 
coop. Not so. The FDA will create a pool of inspectors who then will be 
available to companies, and that is what we call third-party inspection 
in the bill. I think there is a huge difference between the two.
  The bill also creates an Office of Combination Products to shepherd 
advanced products such as devices with drug coding through the approval 
process, so this new administrative flexibility allows the FDA to 
devote its resources to the devices that patients need most.
  Number three, and finally, the bill creates a way to regulate 
reprocessed devices. I have felt pretty strongly about this. I offered 
a bill in the Congress some time ago on it. These are products such as 
needles and catheters, and I think most people do not realize that this 
is done, which are often used a second, third, or fourth time in 
patients after they have been reprocessed. That does raise safety 
concerns, so the bill requires that reprocessed products undergo 
additional scrutiny by the FDA and that they be held to the highest 
standards the FDA can apply.
  I think that this is a real achievement. I have been after the FDA to 
do this for some time, and the bill accomplishes that. I think it is a 
win for the American people.
  It also requires that doctors, who are often unaware that they are 
using reprocessed devices, be informed about the reused device so they, 
in turn, can advise their patients.
  Now I want to close by saying my thanks to the gentleman from 
Pennsylvania (Mr. Greenwood); to the gentleman from Louisiana (Chairman 
Tauzin); to the gentleman from Florida (Chairman Bilirakis); to the 
gentleman from Michigan (Mr. Dingell), the ranking member of the 
Committee on Commerce; to the gentleman from California (Mr. Waxman); 
and certainly to the gentleman from Ohio (Mr. Brown), the ranking 
member of our subcommittee; for their highly cooperative work over the 
last 6 months.
  I also want to single out my own legislative director, Anne Wilson. 
Anne Wilson has literally spent hundreds of hours on this issue. She 
has negotiated on weekends, she has gone to meetings at night, gotten 
home in the morning, and then come into the office. I think that it is 
fair to say that we would not be here this evening were it not for the 
extraordinary work that Anne has done, and we are all grateful to her.
  I also would like to thank Pat Morrissey, Brent Delmonte, and Steve 
Tilton of the staff of the gentleman from Louisiana (Chairman Tauzin); 
Jenny Hansen of the office of the gentleman from North Carolina (Mr. 
Burr), my friend, Mr. Burr; Allen Eisenberg of the office of the 
gentleman from Pennsylvania (Mr. Greenwood); John Ford of the office of 
the gentleman from Michigan (Mr. Dingell); Anne Witt of the office of 
the gentleman from California (Mr. Waxman); and Jeremy Sharp of the 
office of the gentlewoman from California (Mrs. Capps).
  This is an important bill, and it would not have been completed 
without the kind of work that we have all underscored this evening.
  I think we have come a long way, Madam Speaker; and I think we have 
created something that will serve the American people well. I urge the 
entire House to support this important legislation.
  Mr. BROWN of Ohio. Madam Speaker, I have no further requests for 
time, and I yield back the balance of my time.
  Mr. BURR of North Carolina. Madam Speaker, I yield myself such time 
as I may consume.
  Madam Speaker, let me add, before I yield back my time, the fabulous 
commitment that the gentlewoman from California (Ms. Eshoo) has made to 
this bill, as well as the gentleman from Pennsylvania (Mr. Greenwood) 
on our side.
  I think the gentlewoman from California stated it very well: It was 
the ability of those who worked, staff and Members of the Committee on 
Commerce, to stay focused on patients and, ultimately, the advantages 
to those patients that a successful end to this legislation might bring 
to the approval process on medical devices. That means that tonight 
this bill will pass the House of Representatives. For that, I am 
grateful to the gentlewoman from California.
  Mr. GREENWOOD. Madam Speaker, today, we consider in the House under 
suspension H.R. 3580, a bill that I originally introduced with 
congresswoman Anna Eshoo, but has become so much more. Thanks to a 
cooperative and bi-partisan approach, this bill has now become a 
vehicle for an array of reforms that are perhaps the most sweeping for 
medical device reviews since the medical device amendments of 1976.
  First, let me thank chairman Tauzin, chairman Bilirakis, and ranking 
members Dingell and Brown, as well as Mr. Waxman and each of your 
staffs. This has been an outstanding example of teamwork and 
bipartisanship.
  In particular, I want to recognize the following staff for their 
outstanding work on this bill: Brent Delmonte; Patrick Morrisey; David 
Nelson; Anne Wilson; Karen Nelson; John Ford; Ann Witt; Steven Tilton; 
Jenny Hansen; Ellie DeHoney; and Alan Eisenberg. Also I want to thank 
the legislative counsel, Pete Goodloe.
  Madam Speaker, last year many of us became much better versed in some 
of the extraordinary new technologies developed by medical device 
companies as we learned about the pacemaker and defibrilator that Vice 
President Cheney had implanted. Smaller than a deck of cards, 
implantable under the collarbone, and able to be implanted in a one-day 
outpatient procedure, this is a truly remarkable device.
  This is the type of technology that Congress needs to make sure is 
being reviewed quickly and thoroughly by FDA--because these devices 
hold out the promise of making a difference in people's lives.
  Nearly five years ago, we made changes to the FDA when we passed 
FDAMA, to improve the speed and responsiveness of the agency. The 
response to those reforms by the FDA has been, for the most part, 
positive.
  But that is not to say we can't do better. The needs of patients 
demand nothing less. Given that clinical practices are moving more and 
more toward minimally invasive and increasingly complex devices, 
performances improvement by the FDA is vital to our public health.
  H.R. 3580 accomplishes this. It is comprehensive. It will permanently 
alter the landscape for device reviews while maintaining and I believe 
increasing the safeguards of devices as ``Safe and Effective.''
  Let me just briefly mention a few of these provisions.
  User Fee Program. The user fee program on which this committee has 
labored so thoroughly, will provide $40 million to the FDA in

[[Page 19403]]

2003, ramping up to $50 million in 2007 in new resources for speeding 
up the approval of the medical devices. The user fee program at FDA has 
worked wonders for the approval of drugs and biolgics--we just 
reauthorized a third round of PDUFA earlier this year. This will 
finally give the center for devices and radiological health (CDRH) 
access to similar resources so that they can provide thorough, 
effective reviews, in less time. And it will give CDRH the ability to 
make a commitment to meet a complete set of performance goals.
  This bill also incorporates many of the provisions that I introduced 
earlier this year along with Congresswoman Eshoo:
  Streamlined Approval of Combination Products: Combination products, 
such as drug-coated stents, are one of the most exciting areas for this 
industry and present challenges to the FDA's standard review 
mechanisms, resulting in inefficiency and delay. To alleviate these 
problems, this legislation creates a new office of combination products 
and product jurisdiction. This new office will help avoid regulatory 
logjams and ensure that combination products are promptly and correctly 
assigned to centers with the FDA.
  Third Party Inspection. H.R. 3580 also expands the role of third 
parties and outside experts to augment the FDS resources to help FDA 
meet its Bienniel Manufacturing Inspection Requirements. This will be 
done in a carefully prescribed manner, to ensure the FDA's standards 
for inspection are met and that the FDA receives sound information from 
these outside experts.
  Third Party Review. This legislation also extends the use of third 
party review program for one year so that it expires in conjunction 
with other device provisions.
  Reuse Provisions. This bill responds to concerns that many ``Single-
Use'' devices are reprocessed and resold to hospitals, while regulated 
as single-use devices, rather than as multiple-use devices. Concerns 
have also been raised that there are not adequate safeguards to ensure 
the safety and effectiveness of these devices. This legislation 
responds to these concerns with several new provisions that will 
require the FDA to examine reprocessed devices that are presently 
exempt from review and requires labeling of reprocessed devices by the 
reprocessors. Furthermore, under this language a new category of 
devices is created, as well as a new type of application, to ensure 
that complex reprocessed devices are safe and effective for use.
  Medical devices are some of our health care systems' most remarkable 
innovations. The provisions in this bill will allow the FDA to reduce 
review times, increase efficiency of operations and allow these 
technologies to be delivered to patients more quickly. I urge a ``yes'' 
vote on this bill
  Mr. BILIRAKIS. Madam Speaker, Unfortunately due to an unexpected 
passing of a close family friend I was unable to speak in person for my 
strong support of H.R. 3580. However, I am very pleased that you 
brought this legislation forward today and would ask all my colleagues 
to strongly support, H.R. 3580, the Medical Device User Fee and 
Modernization Act of 2002. I believe that this important legislation 
will increase access to breakthrough medical technologies, and improve 
efficiencies at the Food and Drug Administration (FDA).
  This legislation, which enjoys broad bi-partisan support, contains 
three main provisions. First, the legislation authorizes, for the first 
time, a medical device user fee system. This user fee agreement was 
negotiated between the Food and Drug Administration (FDA) and industry, 
and it will provide FDA with the additional resources it needs to speed 
the review of medical devices. I would note that the user fee structure 
is two-tiered, and effectively recognizes the needs of small device 
manufacturers.
  The second part of the bill contains several important regulatory 
reform provisions. Most importantly, the bill authorizes the creation 
of a new 3rd party inspection system for device manufacturing 
facilities. Although required under law to inspect facilities every two 
years, FDA currently only inspects facilities every five to seven 
years. The new 3rd party inspection system will in no way supplant 
resources FDA currently commits to inspect manufacturers--in fact, the 
program will cease to exist if FDA dedicates less resources to 
inspections than it currently does. What this new program will do is 
ensure that more facilities get inspected more often, which is 
beneficial for the public health. This program will also help to 
harmonize international inspections.
  Finally, the legislation contains modifications to FDA's current 
regulatory scheme governing reprocessed single-use devices. I feel that 
the changes represented in this bill strike the right balance between 
respecting the rights of original equipment manufacturers while also 
recognizing the important role for device reprocessors.
  I want to emphasize that this bill is bipartisan, and is the result 
of months of negotiations. Staffs on both sides of the aisle should be 
commended for the good work they put into this product, and I urge all 
Members to strongly support this legislation.
  Ms. DeGETTE. Madam Speaker, I commend Chairman Tauzin and the Ranking 
member of the full Energy and Commerce Committee, Mr. Dingell, as well 
as Mr. Greenwood and Ms. Eshoo for their hard work on this bill. H.R. 
3580 will go a long way toward ensuring that the Food and Drug 
Administration has the necessary resources to quickly, yet efficiently 
and carefully review medical device manufacturer applications.
  Much like the Prescription Drug User Fee Act, reauthorized earlier 
this year in the bioterrorism bill, the House's action today will 
provide our constituents with the best of modern medicine in a more 
timely fashion.
  Passage of this bill will assist all Americans, including the 
youngest Americans--our children. While I am very interested in 
speeding the approval process for devices that treat and cure a range 
of medical conditions in adults and children, I am equally as 
interested in ensuring that these devices are safe and effective for 
use by children.
  That is why I want to thank Chairman Tauzin and Mr. Dingell for 
including my provisions in this bill. My provisions will aid in 
strengthening the bill by ensuring that medical devices are safe and 
effective for use by children.
  To achieve this goal, the bill--in Section 209--now requires the 
Medical Devices Advisory Committee of the Center for Devices and 
Radiological Health to include or consult with pediatric experts when 
reviewing applications for devices that may be used by children.
  The bill also requires, in Section 211, the Secretary of Health and 
Human Services to commission an Institute of Medicine study to examine 
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 children. The IOM is 
requested to pay particular attention to the study length and adequacy 
of FDA resources to monitor longterm studies, in a variety of areas 
including shunts and other implanted devices used for infants and 
children.
  Lastly, the bill's report language will include language recommending 
that a portion of new funds for post-marketing surveillance be used to 
assess long-term use, safety and effectiveness of medical devices in 
children. This language is key as children rapidly grow and a device 
implanted at age eight, for example an implantable insulin pump for 
diabetics, may not work as effectively or safely at age 12.
  These additions to the bill will ensure that like adults, children 
will receive the best health care possible. Again, I thank Chairman 
Tauzin and Ranking Member Dingell for working with me to address these 
issues.
  Mr. DINGELL. Madam Speaker, I support H.R. 3580, the ``Medical Device 
User Fee and Modernization Act of 2002.'' This bill, for the first 
time, creates a user fee program for the pre-market review of medical 
devices. This is an important step toward providing the Food and Drug 
Administration (FDA) with adequate resources to do the job of ensuring 
that the vast and often complex array of medical device applications 
the Agency receives each year are reviewed in a timely and competent 
manner.
  Important safeguards in this legislation ensure that timeliness of 
product application review does not come at the cost of the Federal 
Food, Drug, and Cosmetic Act's gold standard for ensuring that those 
devices are safe and effective for their intended use. It also provides 
a down payment on an increased level of post-market surveillance and 
provides a process to increase this critical compliance activity when 
we next authorize user fees.
  This Act also addresses standards for reuse of devices that have been 
approved for a single use. This practice, while widespread, was largely 
unregulated until recently. Unfortunately, the FDA's attempt to correct 
the matter was, to put it charitably, controversial and, from the 
perspective of protecting the consuming public, lacking. The bill 
before us strikes a balance among competing interests, while 
strengthening FDA's role with respect to assuring the safety of these 
products.
  This bill also establishes a program that for the first time will 
allow third parties to inspect medical device facilities. The guiding 
principle for me in going down this road is that the program must 
supplement--and not supplant--FDA's legal authority, responsibility, 
and resources for conducting inspections and otherwise ensuring the 
safety of device facilities. I remain concerned about the proper 
implementation of this third-party inspection program and will closely 
watch its development.

[[Page 19404]]

  Finally, the bill contains a number of regulatory reforms. These 
include electronic labeling, establishment of an office of combination 
products, provision for modular review of product applications, and 
important incentives for the industry to study the application of their 
devices to children.
  The Medical Device User Fee and Modernization Act deserves our 
support. It is a bipartisan product in the best tradition of the 
Committee on Energy and Commerce. Members on both sides of the aisle 
have worked hard on this bill. In addition to my colleagues 
Representatives Brown and Waxman, particular credit should go to 
Representatives Capps, Eshoo, Luther, and Towns who have long sought 
these reforms. And, of course, Chairman Tauzin and Chairman Bilirakis 
are to be commended for their efforts and their commitment to a 
bipartisan product. This bill is good for both consumers and industry, 
and I urge its support.
  Mr. BURR of North Carolina. Madam Speaker, I yield back the balance 
of my time.
  The SPEAKER pro tempore (Ms. Hart). The question is on the motion 
offered by the gentleman from North Carolina (Mr. Burr) that the House 
suspend the rules and pass the bill, H.R. 3580, as amended.
  The question was taken.
  The SPEAKER pro tempore. In the opinion of the Chair, two-thirds of 
those present have voted in the affirmative.
  Mr. BURR of North Carolina. Madam Speaker, on that I demand the yeas 
and nays.
  The yeas and nays were ordered.
  The SPEAKER pro tempore. Pursuant to clause 8 of rule XX and the 
Chair's prior announcement, further proceedings on this motion will be 
postponed.

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