Studies criticize U.S. medical device approval process

The FDA's less-stringent 510(k) clearance process comes under fire (again) in a pair of new studies.

NEW YORK (Reuters Health) - Information on the safety and effectiveness of medical devices before and after they are cleared by U.S. health regulators can be improved, according to 2 new studies.

Food & Drug Administration (FDA)

News Well, 510(k) reforms, Regulatory/Compliance

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