FDA offers new guidance on 510(k) risk/benefit review

The FDA's medtech office issues new draft guidance to clarify the agency's risk/benefit evaluation process for technologies undergoing 510(k) review.

Federal medical device regulators issued new draft guidance this week hoping to clarify the agency's process for determining the benefits and risks of 510(k) devices.

The new guidance wouldn't change any of the FDA's existing policies for evaluating 510(k) submissions, but the agency hopes the document will help device makers better understand the agency's thinking.

Center for Devices and Radiological Health (CDRH), Food & Drug Administration (FDA)

News Well, 510(k), 510(k) reforms, Food & Drug Administration (FDA), Regulatory/Compliance

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