Date: December 18, 2015
The following new items were added to the CDRH web pages on December 17, 2015. Previous CDRH New Items can be found on theCDRHNew Page.
- Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring
- Consumer Information on: LifeVest Wearable Cardioverter Defibrillator - P010030S056
- Federal Register: Medical Device ISO 13485:2003 Voluntary Audit Report Pilot Program; Termination of Pilot Program; Announcement of the Medical Device Single Audit Program Operational Phase