Pub.L. 107-251 To amend the Public Health Service Act to reauthorize and strengthen the ...

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          MEDICAL DEVICE USER FEE AND MODERNIZATION ACT OF 2002

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Public Law 107-250
107th Congress

                                 An Act


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

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

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

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

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

Sec. 1. Short title; table of contents.

                TITLE I--FEES RELATED TO MEDICAL DEVICES

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

      TITLE II--AMENDMENTS REGARDING REGULATION OF MEDICAL DEVICES

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

                    TITLE III--ADDITIONAL AMENDMENTS

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

[[Page 116 STAT. 1589]]

                TITLE I--FEES RELATED TO MEDICAL DEVICES

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

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

SEC. 102. ESTABLISHMENT OF PROGRAM.

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

                   ``PART 3--FEES RELATING TO DEVICES

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

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

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

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                    ``(I) Any activity undertaken under section 513 or 
                515(i) in connection with the initial classification or 
                reclassification of a device or under section 515(b) in 
                connection with any requirement for approval of a 
                device.
                    ``(J) Evaluation of postmarket studies required as a 
                condition of an approval of a premarket application 
                under section 515 or section 351 of the Public Health 
                Service Act.
                    ``(K) Compiling, developing, and reviewing 
                information on relevant devices to identify safety and 
                effectiveness issues for devices subject to premarket 
                applications, premarket reports, supplements, or 
                premarket notification submissions.
            ``(6) The term `costs of resources allocated for the process 
        for the review of device applications' means the expenses 
        incurred in connection with the process for the review of device 
        applications for--
                    ``(A) officers and employees of the Food and Drug 
                Administration, contractors of the Food and Drug 
                Administration, advisory committees, and costs related 
                to such officers, employees, and committees and to 
                contracts with such contractors;
                    ``(B) management of information, and the 
                acquisition, maintenance, and repair of computer 
                resources;
                    ``(C) leasing, maintenance, renovation, and repair 
                of facilities and acquisition, maintenance, and repair 
                of fixtures, furniture, scientific equipment, and other 
                necessary materials and supplies; and
                    ``(D) collecting fees and accounting for resources 
                allocated for the review of premarket applications, 
                premarket reports, supplements, and submissions.
            ``(7) The term `adjustment factor' applicable to a fiscal 
        year is the Consumer Price Index for all urban consumers (all 
        items; United States city average) for April of the preceding 
        fiscal year divided by such Index for April 2002.
            ``(8) The term `affiliate' means a business entity that has 
        a relationship with a second business entity if, directly or 
        indirectly--
                    ``(A) one business entity controls, or has the power 
                to control, the other business entity; or
                    ``(B) a third party controls, or has power to 
                control, both of the business entities.

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

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

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                          ``(ii) For a premarket report, a fee equal to 
                      the fee that applies under clause (i).
                          ``(iii) For a panel track supplement, a fee 
                      equal to the fee that applies under clause (i).
                          ``(iv) For a 180-day supplement, a fee equal 
                      to 21.5 percent of the fee that applies under 
                      clause (i), subject to any adjustment under 
                      subsection (c)(3).
                          ``(v) For a real-time supplement, a fee equal 
                      to 7.2 percent of the fee that applies under 
                      clause (i).
                          ``(vi) For an efficacy supplement, a fee equal 
                      to the fee that applies under clause (i).
                          ``(vii) For a premarket notification 
                      submission, a fee equal to 1.42 percent of the fee 
                      that applies under clause (i), subject to any 
                      adjustment under subsection (c)(3) and any 
                      adjustment under subsection (e)(2)(C)(ii).
                    ``(B) Exceptions.--
                          ``(i) Humanitarian device exemption.--An 
                      application under section 520(m) is not subject to 
                      any fee under subparagraph (A).
                          ``(ii) Further manufacturing use.--No fee 
                      shall be required under subparagraph (A) for the 
                      submission of a premarket application under 
                      section 351 of the Public Health Service Act for a 
                      product licensed for further manufacturing use 
                      only.
                          ``(iii) State or federal government 
                      sponsors.--No fee shall be required under 
                      subparagraph (A) for a premarket application, 
                      premarket report, supplement, or premarket 
                      notification submission submitted by a State or 
                      Federal Government entity unless the device 
                      involved is to be distributed commercially.
                          ``(iv) Premarket notifications by third 
                      parties.--No fee shall be required under 

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