CDRH New Update

CDRHNew

Date: August 9, 2016

The following new items were added to the CDRH web pages on August 8, 2016. Previous CDRH New Items can be found on theCDRHNew Page.

• Federal Register: Deciding When To Submit a 510(k) for a Change to an Existing Device; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
• Federal Register: Deciding When To Submit a 510(k) for a Software Change to an Existing Device; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
• Meeting materials posted for August 10, 2016 Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee meeting
• Federal Register: Retrospective Review of Premarket Approval Application Devices Striking the Balance Between Premarket and Postmarket Data Collection