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United States · Law · HR

H.R. 5651 (107th)

Medical Device User Fee and Modernization Act of 2002

enactedUnited States· United States Congress· EN

Introduced

16 October 2002

Last action

26 October 2002 · President

Status

Became Public Law No: 107-250.

Sponsors

Rep. Greenwood, James C. [R-PA-8], Rep. Eshoo, Anna G. [D-CA-18]

Subjects

Healthcare

Source updated

7 April 2025

Healthcare

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Summary

Amends the Federal Food, Drug, and Cosmetic Act to establish a new program that subjects, beginning on October 1, 2002, each medical device manufacturer to a medical device fee for certain applications, reports, application supplements, and submissions sent to the Food and Drug Administration for evaluation. Grants exceptions. Restricts the medical device user fees collected to being used to defray increases in the costs of the resources allocated for the review of device applications. Exempts certain entities submitting premarket reports from being subject to a fee. Directs the Secretary to accredit persons who are not Federal employees to conduct the inspections required under the Act for establishments that manufacture, prepare, propagate, compound, or process class II or class III devices. Considers it a violation of the Act for an accredited inspector to: (1) breach the standards of accreditation of this section; (2) pose a threat to public health; or (3) fail to act in accordance with this section. Requires the Secretary to establish within the Office of the Commissioner of Food and Drugs an Office to perform various functions, including to ensure the timely premarket review of combination products. Directs the Secretary to provide guidance on ensuring safety of pediatric devices and providing protections for pediatric subjects in clinical investigations into the safety and effectiveness of such devices. Requires reprocessed single-use devices to carry prominently on the label a statement identifying the product as such, along with the name of the person responsible for reprocessing and the manufacturer.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

  1. 16 October 2002

    Passed

    Motion to reconsider laid on the table Agreed to without objection.

    Source: Floor

  2. 16 October 2002

    Floor

    Considered by unanimous consent.

    Source: Floor

  3. 16 October 2002

    Passed

    On passage Passed without objection. (text: CR H7965-7974)

    Source: Floor

  4. 16 October 2002

    Passed

    Passed/agreed to in House: On passage Passed without objection.(text: CR H7965-7974)

    Source: Floor

  5. 16 October 2002

    Introduced

    Received in the Senate, read twice.

    Source: IntroReferral

  6. 16 October 2002

    Introduced

    Introduced in House

    Source: IntroReferral

  7. 16 October 2002

    Discharge

    Committee on Energy and Commerce discharged. (consideration: CR H7964-8009)

    Source: Discharge

  8. 16 October 2002

    Committee

    Committee on Energy and Commerce discharged.(consideration: CR H7964-8009)

    Source: Committee

  9. 16 October 2002

    Floor

    Mr. Armey asked unanimous consent to discharge from committee and consider.

    Source: Floor

  10. 16 October 2002

    Introduced

    Referred to the House Committee on Energy and Commerce.

    Source: IntroReferral

  11. 16 October 2002

    Introduced

    Introduced in House

    Source: IntroReferral

  12. 17 October 2002

    Passed

    Passed Senate without amendment by Unanimous Consent. (consideration: CR S10752-10754)

    Source: Floor

  13. 17 October 2002

    Passed

    Passed/agreed to in Senate: Passed Senate without amendment by Unanimous Consent.(consideration: CR S10752-10754)

    Source: Floor

  14. 18 October 2002

    Floor

    Message on Senate action sent to the House.

    Source: Floor

  15. 25 October 2002

    Floor

    Presented to President.

    Source: Floor

  16. 25 October 2002

    President

    Presented to President.

    Source: President

  17. 26 October 2002

    Became law

    Became Public Law No: 107-250.

    Source: President

  18. 26 October 2002

    Became law

    Signed by President.

    Source: BecameLaw

  19. 26 October 2002

    President

    Signed by President.

    Source: President

Votes

No vote records are attached yet.

Versions

Documents

12 official files

Enrolled Bill (text)

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  • Enrolled Bill (text)

    Enrolled Bill · EN

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  • Enrolled Bill (PDF)

    Enrolled Bill · EN

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  • Public Law (text)

    Public Law · EN · 26 October 2002

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  • Public Law (PDF)

    Public Law · EN · 26 October 2002

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  • Received in Senate (text)

    Received in Senate · EN · 16 October 2002

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  • Received in Senate (PDF)

    Received in Senate · EN · 16 October 2002

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  • Engrossed in House (text)

    Engrossed in House · EN · 16 October 2002

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  • Engrossed in House (PDF)

    Engrossed in House · EN · 16 October 2002

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  • Introduced in House (text)

    Introduced in House · EN · 16 October 2002

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  • Introduced in House (PDF)

    Introduced in House · EN · 16 October 2002

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  • Passed House without amendment

    summary · EN · 16 October 2002

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  • Introduced in House

    summary · EN · 16 October 2002

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