FDA moves toward tighter medical device oversight

08.04.10
Publication: Associated Press By: Matthew Perrone

WASHINGTON — Makers of X-ray machines, drug pumps and other medical devices would have to submit more safety information to win federal approval under a proposal designed to tighten regulation of thousands of products reviewed each year.

The Food and Drug Administration released recommendations Tuesday night designed to improve oversight of the U.S. device industry, including the government’s ability to revoke approval for products that prove unsafe or ineffective.

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