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FDA moves toward tighter medical device oversight
San Francisco Chronicle

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. The FDA’s report comes nearly a year after FDA’s medical devices division endured a storm of criticism from public health advocates and lawmakers.