CDRH New Update

The following new items were added to the CDRH web pages on September 5, 2018. Previous CDRH New items can be found on the CDRH New webpage.

• New Program with Payors Aims to Accelerate Patient Access to Medical Devices
• Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions - Draft Guidance for Industry and Food and Drug Administration Staff