CDRHNew
Date: April 17, 2014
The following new items were added to the CDRH web pages on April 16, 2014. Previous CDRH New Items can be found on the CDRHNew Page.
- Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices - Draft Guidance for Industry and Food and Drug Administration Staff
- Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials - Draft Guidance for Institutional Review Boards, Industry, Investigators, and Food and Drug Administration Staff
- Federal Register: Proposed Strategy and Recommendations for a Risk-Based Framework for Food and Drug Administration Safety and Innovation Act Health Information Technology; Public Workshop; Request for Comments
- Class I Medical Device Recall: Spacelabs Healthcare Ltd., ARKON Anesthesia Delivery System with Version 2.0 Software - Software Defect May Cause System to Stop Working
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