Date: December 19, 2016
The following new items were added to the CDRH web pages on December 16, 2016. Previous CDRH New Items can be found on the CDRHNew Page.
- Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulation That Suffer From a Disease or Condition That a Device Is...
- Emergency Use Authorizations: RealStar® Zika Virus RT-PCR Kit U.S. (altona Diagnostics)
- Class I Medical Device Recall: Greatbatch Medical Recalls Standard Offset Cup Impactor Used for Hip Joint Replacement due to Inadequate Sterilization
- Information on Medical Cribs Used in Homes and Child Care Settings - Updated
- Medical Gloves - Updated