CDRH New Update

The following new items were added to the CDRH web pages on February 21, 2019. Previous CDRH New items can be found on the CDRH New webpage.

• Acceptance of Data from Clinical Investigations for Medical Devices
• Webinar - Implementation of Final Rule on Human Subject Protection: Acceptance of Data from Clinical Investigations for Medical Devices - March 19, 2019
• Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) - Guidance for Industry and Food and Drug Administration Staff
• Refuse to Accept Policy for 510(k)s - Guidance for Industry and Food and Drug Administration Staff
• Presentation and Transcript added to Webinar - Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices - February 12, 2019