Date: June 30, 2016
The following new items were added to the CDRH web pages on June 29, 2016. Previous CDRH New Items can be found on theCDRHNew Page.
- Emergency Use Authorizations: Zika MAC-ELISA (CDC) Updated June 29, 2016
- Class I Medical Device Recall: HeartWare Inc. Extends Recall to Include Batteries Used in the Ventricular Assist Device Due to Premature Power Depletion
- Federal Register: Medical Devices; General and Plastic Surgery Devices; Classification of the Electrosurgical Device for Over-the-Counter Aesthetic Use
- Meeting Notice: August 16, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee
- Federal Register: Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments