CDRHNew
Date: July 5, 2012
The following new items were added to the CDRH web pages on July 3, 2012. Previous CDRH New Items can be found on the CDRHNew Page.
- Unique Device Identification
- FDA Safety Communication: Advanced Sterilization Products (ASP) Sterrad Cyclesure 24 Biological Indicators Revised Expiration Dates
- Guidance for Industry and FDA Staff - Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions
- Guidance for Industry and Food and Drug Administration Staff - Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions
- Federal Register: Guidances for Industry and Food and Drug Administration Staff: Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data--Premarket Notification (510(k)) Submissions; and Clinical Performance Assessment: Considerations...
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