Date: July 29, 2016
The following new items were added to the CDRH web pages on July 28, 2016. Previous CDRH New Items can be found on theCDRHNew Page.
- Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Pre-Submission Program for Medical Devices
- Class I Medical Device Recall: CareFusion AVEA Ventilator
- General Wellness: Policy for Low Risk Devices - Guidance for Industry and Food and Drug Administration Staff
- Webinar Presentation and Transcript added to Final Guidance on Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process