Law360, New York (May 01, 2012, 6:10 PM ET) -- On March 27, 2012, the U.S. Food and Drug Administration released a final guidance document describing the principal factors the agency will consider when making benefit-risk determinations for medical devices subject to the premarket review and de novo classification processes, respectively.
The final guidance, entitled "Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications," describes the types of medical devices to which the guidance applies, identifies the types of scientific evidence FDA will consider when making benefit-risk determinations, enumerates...
FDA Revised Benefit-Risk Criteria — Embracing Innovation
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