Summary: H.R.3580 — 107th Congress (2001-2002)All Information (Except Text)

Bill summaries are authored by CRS.

Shown Here:
Passed House amended (10/09/2002)

Medical Device User Fee and Modernization Act of 2002 - Title I: Fees Related to Medical Devices - (Sec. 102) 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, including for humanitarian devices and certain devices sponsored by State governments or the Federal Government. Directs the Secretary of Health and Human Services to waive one premarket application, or one premarket report, where the applicant is a small business submitting its first premarket application, or its first premarket report, respectively, for review. Reduces fees for small businesses.

Sets performance goals with respect to the amount appropriated for the Food and Drug Administration for devices and radiological products providing that the appropriations reach a certain level.

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. Authorizes appropriations. Exempts certain entities submitting premarket reports from being subject to a fee, including a person filing his first such report if before October 1, 2002, the person submitted a premarket application for the same device.

(Sec. 103) Establishes requirements for reporting by the Secretary concerning performance goals and fees.

(Sec. 104) Authorizes appropriations for the postmarket surveillance of medical devices.

Directs the Secretary to conduct a study regarding the medical device user-fee program established under this Act.

(Sec. 105) Directs the Secretary to consult with the Committee on Energy and Commerce of the House of Representatives, the Committee on Health, Education, Labor, and Pensions of the Senate, and various other entities in: (1) developing recommendations to Congress for goals and plans related to the review of medical device applications for fiscal years after 2007; and (2) completing the reauthorization of parts of the Federal Food, Drug, and Cosmetic Act.

(Sec. 107) Sets a sunset date of October 1, 2007, for the amendments regarding fees related to medical devices, except that the reporting requirements shall cease to be effective January 31, 2008.

Title II: Amendments Regarding Regulation of Medical Devices - (Sec. 201) 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. Requires the Secretary to publish in the Federal Register criteria to accredit or deny accreditation to persons who request to perform such inspections. Sets forth minimum requirements for inspectors and qualifications establishments must meet to receive inspectors.

Directs the Comptroller General to determine the amount obligated by the Secretary for fiscal year 2002 for FDA compliance activities with respect to devices, and of such amount, the amount obligated for inspections of device establishments. Establishes reporting requirements for the Comptroller General. Sets a sunset date of October 1, 2012, for the provisions of this section.

(Sec. 202) Sets a sunset date of October 1, 2007, for the third-party accreditation program authority. Establishes a requirement for the Secretary to report to Congress after conducting a study based on the experience under such program.

(Sec. 203) 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 Office to consult with the relevant component within the Office of the Commissioner of Food and Drugs in performing its duties.

Directs the Secretary, acting through the office, to review each agreement, guidance, or practice of the Secretary that is specific to the assignment of combination products to agency centers to verify compliance with the requirements of this Act. Establishes reporting requirements for the Secretary.

(Sec. 204) Directs the Secretary to report to Congress on the timeliness and effectiveness of device premarket reviews by centers other than the Center for Devices and Radiological Health.

(Sec. 205) Allows labeling for prescription devices intended for use in health care facilities to be made available solely by electronic means, provided that a manufacturer furnishes a paper copy for free upon request by a health care facility.

(Sec. 206) Requires that specified submissions regarding registration of producers of drugs and devices shall be made electronically, upon a finding by the Secretary that such action is feasible. Permits the Secretary to grant waivers of such requirement.

(Sec. 207 ) Eliminates the sunset for certain provisions regarding intended (human) use for substantial equivalence determinations.

(Sec. 208) Provides for modular review by the Secretary of applications for premarket approval of class III devices.

(Sec. 209) Directs the Secretary to require that a panel advising on premarket approval of a class III device must include, or consult with, one or more pediatric experts if there is a reasonable likelihood of the device being used in a pediatric population.

(Sec. 210) Requires the Secretary to publish on the Internet lists of each type of class II device not requiring a report in order to provide reasonable assurance of the devices' safety and effectiveness.

(Sec. 211) Requires the Secretary to request the Institute of Medicine to conduct a study to determine whether the system under the Federal Food, Drug, and Cosmetic Act for postmarket surveillance regarding pediatric populations is adequate.

(Sec. 212) 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.

(Sec. 213) Requires the Comptroller General to conduct a study of breast implants, including to determine the number of adverse events that have been reported and whether such events have been adequately investigated. Establishes reporting requirements.

(Sec. 214) Requires the Director of the National Institutes of Health to submit to Congress a report describing the status of research on breast implants. Requires the Director to conduct or support prospective or retrospective research to examine the long-term health implications of both saline and silicone breast implants.

Title III: Additional Amendments - (Sec. 301) Requires the identification of the manufacturer of a medical device to be displayed on the device or an attachment thereto, with exemptions allowed to be issued by the Secretary.

(Sec. 302) 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. States that such provision shall cover devices introduced or delivered for introduction into interstate commerce after the date 15 months following the passage of this Act.

Amends provisions regarding registration of producers of drugs and devices, including with respect to: (1) certain reprocessed single-use devices that require reports preceding introduction into interstate commerce; (2) such devices that do not require reports; and (3) such devices classified as class III and for which a premarket application is required.