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FDA moves toward tighter medical device oversight

Atlanta Journal-Constitution/AP, August 4, 2010

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. Last August, the head of the device division resigned, months after scientists under his leadership alleged they were pressured to approve certain products. Last year began with congressional investigators saying the FDA should take immediate steps to make sure more devices are reviewed through the most stringent process.