CDRHNew
Date: February 15, 2013
The following new items were added to the CDRH web pages on February 14, 2013. Previous CDRH New Items can be found on the CDRHNew Page.
- Accreditation and Reaccreditation Process for Firms under the Third Party Review Program: Part I - Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Reviewers
- Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation - Guidance for Industry and Food and Drug Administration Staff
- Class I Medical Device Recall: GE Healthcare, LLC, Giraffe and Panda T-Piece Resuscitation Systems, and the Giraffe and Panda Bag and Mask Resuscitation Systems
- PMA Final Decisions for December 2012
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