Medical Device User Fee and Modernization Act of 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 a…

Congressional Research Service · 2002-10-16