CDRHNew
Date: April 12, 2016
The following new items were added to the CDRH web pages on April 11, 2016. Previous CDRH New Items can be found on theCDRHNew Page.
- Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Detention and Banned Medical Devices
- Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Cover Sheet, Form FDA 3601
- Class I Medical Device Recall: Dexcom Inc. Recalls G4 Platinum and G5 Mobile Continuous Glucose Monitoring System Receivers Due to Audible Alarm Failure
- MQSA Insights - Poor Positioning Responsible For Most Clinical Image Deficiencies, Failures
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