Date: October 31, 2016
The following new items were added to the CDRH web pages on October 28, 2016. Previous CDRH New Items can be found on the CDRHNew Page.
- Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products
- Consumer Information on: AMPLATZER PFO Occluder - P120021
- Federal Register: Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of Zika Virus; Availability
- Class I Medical Device Recall: HeartWare Recalls Ventricular Assist Device Controllers Due to Loose Connectors which may Prevent Alarm from Sounding and Pump Stops
- Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization - Guidance for Industry and Food and Drug Administration Staff