The U.S. Food & Drug Administration (FDA) has released a final guidance document entitled, “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications,...more
9/26/2019
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FDA Approval ,
FDA De Novo Clearance ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
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Medical Devices ,
Patient Access ,
Premarket Approval Applications ,
Transparency
On July 9, 2019, the U.S. Food & Drug Administration (FDA) released the final guidance document “Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry,” which provides information...more