PlainBillCongress, translated.Legislation. Context. Public interest.Became Public Law No: 107-250.
Congressional Research Service
Version 00 · Introduced in House · Oct 16, 2002
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.
People & committees
Rep. Greenwood, James C. [R-PA-8] · R–PA
Legislative record
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Became Public Law No: 107-250.
Became Public Law No: 107-250.
Signed by President.
Signed by President.
Presented to President.
Presented to President.
Message on Senate action sent to the House.
Passed Senate without amendment by Unanimous Consent. (consideration: CR S10752-10754)
Passed/agreed to in Senate: Passed Senate without amendment by Unanimous Consent.(consideration: CR S10752-10754)
Received in the Senate, read twice.
Motion to reconsider laid on the table Agreed to without objection.
Considered by unanimous consent.
On passage Passed without objection. (text: CR H7965-7974)
Passed/agreed to in House: On passage Passed without objection.(text: CR H7965-7974)
Committee on Energy and Commerce discharged. (consideration: CR H7964-8009)
Committee on Energy and Commerce discharged.(consideration: CR H7964-8009)
Mr. Armey asked unanimous consent to discharge from committee and consider.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Introduced in House
Primary sources
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Source last updated: Apr 7, 2025. Consult Congress.gov for the current record.
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