Page:United States Statutes at Large Volume 116 Part 2.djvu/807

 PUBLIC LAW 107-250—OCT. 26, 2002 116 STAT. 1589 TITLE I~FEES RELATED TO MEDICAL DEVICES SEC. 101. FINDINGS. 21 USC 379i 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. DEFINITIONS. 21 USC 379i. "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 paneltrack 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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