HR 5545 · 94th Congress · Health
Medical Device Amendments
Bill Progress
✓
Introduced2
Committee3
House Vote4
Senate5
EnactedLatest: Referred to House Committee on Interstate and Foreign Commerce.(1975-03-26)
Plain Language Summary
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Medical Device Amendments - Revises the Federal Food, Drug, and Cosmetic Act to provide for the safety and effectiveness of medical devices intended for human use. Establishes classifications for such devices based upon their safety and effectiveness. Directs the Secretary of Health, Education, and Welfare to classify all such devices. Authorizes the Secretary to establish panels of experts for the purpose of securing recommendations with respect to such classifications. Provides that, based on new information respecting a device, the Secretary may, upon his own initiative or upon petition of an interested person, by regulation: (1) change such device's classification; and (2) revoke, because of the change in classification, any regulation in effect with respect to such device. Authorizes the Secretary to establish a performance standard for those devices for which reasonable assurance for the safety and effectiveness of the device cannot be made. Sets forth criteria to be followed in establishing such standard. Directs the Secretary to provide for periodic evaluation of performance standards established under this Act. Establishes procedures to be followed by the Secretary in deve…
Summarized by Claude AI · Non-partisan · For informational purposes only
Cosponsors (12)
8 Democrats4 Republicans