CDRH New Update

CDRHNew

Date: November 8, 2016

The following new items were added to the CDRH web pages on November 7, 2016. Previous CDRH New Items can be found on the CDRHNew Page.

• Federal Register: Clinical Considerations for Investigational Device Exemptions for Neurological Devices Targeting Disease Progression and Clinical Outcomes; Guidance for Industry and Food and Drug Administration Staff; Availability
• Federal Register: Establishment of the Patient and Care-Partner Connection; Establishment of a Public Docket; Request for Comments
• Medical Device Reporting for Manufacturers - Guidance for Industry and Food and Drug Administration Staff
• Meeting materials posted for November 9-10, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee
• MRI Safety Posters
• Webinar - Final Guidance on Medical Device Reporting for Manufacturers - November 30, 2016