Assessing Patient Impact From Recalls Often A Judgment Call, US FDA Says

Industry participants on an FDA-convened webinar asked for further guidance on how to evaluate the effects enforcement actions might have on patients and the public health. The webinar was organized to discuss a recent FDA draft guidance on benefit-risk considerations for post-market decisions.

Recent US FDA draft guidance on benefit-risk considerations for enforcement actions doesn’t give specific standards for how manufacturers should weigh the potential public impact of a recall. But that could change if comments on the draft ask for the information, a device center official said during a July 11 webinar discussing the draft document that was issued in June.

Multiple participants in the webinar asked for more information on how companies should evaluate what potential effect an enforcement action...

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