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Guidance on Benefit-Risk Determinations in Device Approval

03/28/2012

Federal Register Notice: FDA is making available a guidance document, Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications. It is intended to provide greater clarity on the agency’s decisionmaking process on benefit-risk determinations in the premarket review of medical devices in the premarket approval and de novo pathways. To download this guidance, click here. To view this notice, click here.

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