CDRHNew
Date: July 28, 2014
The following new items were added to the CDRH web pages on July 25, 2014. Previous CDRH New Items can be found on the CDRHNew Page.
- Federal Register: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Annual Reporting for Custom Device Exemption
- Federal Register: Gastroenterology-Urology Devices; Reclassification of Implanted Blood Access Devices
- Class I Medical Device Recall: GE Healthcare, LLC, Single-Width Airway Modules (E-MiniC) and Accessories and Extension Modules (N-FC, N-FCREC) - CO2 Detector May Fail Leading to Injury
- Federal Register: Medical Devices; Gastroenterology-Urology Devices; Classification of the Implantable Transprostatic Tissue Retractor System
- The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] - Guidance for Industry and Food and Drug Administration Staff (PDF - 843kb)
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