CDRHNew
Date: June 26, 2014
The following new items were added to the CDRH web pages on June 25, 2014. Previous CDRH New Items can be found on the CDRHNew Page.
- Global Unique Device Identification Database (GUDID) - Guidance for Industry and Food and Drug Administration Staff (PDF - 2.8MB)
- Mammography Facility Adverse Event and Action Report - June 24, 2014
- Federal Register: Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
- Class I Medical Device Recall: Nitinol Devices and Components, Inc., HydroFinity Hydrophilic Guidewire - May be Damaged during Use and May Lead to Injury
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