S 1446 · 93th Congress · Health

Medical Device Safety Act

Introduced 1973-04-03· Sponsored by Sen. Javits, Jacob K. [R-NY]· Senate

Bill Progress

Introduced
2
Committee
3
Senate Vote
4
House
5
Enacted
Latest: Referred to Senate Committee on Labor and Public Welfare.(1973-04-03)

Plain Language Summary

[AI summary unavailable — showing source text] Medical Device Safety Act - Title I: Authority to Establish Standards - Authorizes the Secretary of Health, Education, and Welfare to establish safety standards for medical devices. Provides that such standards may include provisions for the testing of the device, and may prescribe the form of instructions or warnings necessary for the proper installation, maintenance, operation, and use of the device. Authorizes the Secretary to promulgate a standard governing the performance or other characteristics of a medical device whenever, in his judgment, a standard is necessary to reduce or eliminate unreasonable risk of illness or injury associated with exposure to or use of the device, and there are no other more practicable means to protect the public. Requires the Secretary, prior to the initiation of a proceeding to promulgate a standard, and prior to publishing a proposed standard in the course of such proceeding, to consult with other Federal agencies concerned with standard setting and other nationally or internationally recognized standard-setting agencies or organizations, and to use the technical support of other Federal agencies. Provides that the Secretary would initiate a pr…

Summarized by Claude AI · Non-partisan · For informational purposes only

Cosponsors (4)

4 Republicans