PlainBillCongress, translated.Legislation. Context. Public interest.Read twice and referred to the Committee on Labor and Human Resources.
Congressional Research Service
Version 00 · Introduced in Senate · Oct 31, 1995
Medical Technology, Public Health, and Innovation Act of 1995 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to mandate the adoption of performance standards established by nationally and internationally recognized standard-setting entities regarding determining the safety and effectiveness of class III medical devices. Prohibits requiring, as a condition for premarket approval, conformity with such standards if the applicant submits data other than that required by the standard to demonstrate a reasonable assurance of safety and effectiveness. Requires, in lieu of requiring data demonstrating the conformity of a class III device with such a standard, acceptance of an applicant's certification that the device conforms with each standard identified in the application. (Sec. 4) Modifies premarket approval application requirements, including regulating the circumstances in which submission of preclinical data and information may be required. Requires acceptance of retrospective or historical clinical data as a control or for use in determining whether there is reasonable assurance of safety and effectiveness in certain circumstances. Prohibits requiring clinical trials using randomized controls for a modification to a device if specified conditions exist. Modifies requirements regarding action on premarket approval applications. Mandates elimination of premarket approval of supplements that relate to manufacturing and product changes of a device that can be demonstrated through appropriate methods to not affect safety or effectiveness adversely. (Sec. 5) Mandates exemption from requirements regarding notification preceding introduction of devices into interstate commerce concerning class I and II devices for which notification is not necessary to provide a reasonable assurance of safety and effectiveness. Prohibits requiring additional notifications for a change or modification to certain devices in specified circumstances. (Sec. 6) Modifies requirements regarding investigational device exemptions from certain requirements. (Sec. 7) Establishes the Food and Drug Policy and Performance Review Panel.
People & committees
Sen. Wellstone, Paul D. [D-MN] · D–MN
Legislative record
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Read twice and referred to the Committee on Labor and Human Resources.
Sponsor introductory remarks on measure. (CR S16422)
Introduced in Senate
Primary sources
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Source last updated: Aug 21, 2025. Consult Congress.gov for the current record.
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