FDA Seeks Comments on Postmarket Risk Assessments

FDA Seeks Comments on Postmarket Risk Assessments

FDA may revise medical device risk assessments in postmarket settings.  After a medical device receives FDA approval, new or previously unknown risks can arise. The FDA is now considering ways to conduct better postmarket risk assessments and identify appropriate remedial actions. It is seeking public comments through May 20, 2015. [3/25/15]

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