CDRHNew
Date: April 23, 2013
The following new items were added to the CDRH web pages on April 22, 2013. Previous CDRH New Items can be found on the CDRHNew Page.
- Class I Medical Device Recall: CareFusion Corporation, Alaris PC Unit (Model 8015) with Software Version 9.12
- Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes (New Memos Available)
- Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' - Draft Guidance for Industry and Food and Drug Administration Staff
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