Date: December 31, 2014
The following new items were added to the CDRH web pages on December 30, 2014. Previous CDRH New Items can be found on the CDRHNew Page.
- Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices
- Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance: Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program
- Summary Information for: Bellafill
- Summary Information for: BRACAnalysis CDx
- Consumer Information on: BRACAnalysis CDx - P140020
- Federal Register: Radiation Biodosimetry Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability