The U.S. Food and Drug Administration (FDA) recently issued final guidance regarding the initiation of voluntary product recalls “to help companies prepare to quickly and effectively remove violative products from the...more
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 ,
Manufacturers ,
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