CDRHNew
Date: July 15, 2015
The following new items were added to the CDRH web pages on July 14, 2015. Previous CDRH New Items can be found on theCDRHNew Page.
- Added Discussion Paper and Appendix 1 to Public Workshop - Robotically-Assisted Surgical Devices: Challenges and Opportunities, July 27-28, 2015
- Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach To Monitoring
- Mammography Facility Adverse Event and Action Report - July 15, 2015: Bio Family Clinic PC
- MDUFA Information Consolidated and Relocated
- Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices - Draft Guidance for Industry and Food and Drug Administration Staff
- Federal Register: Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
- UDI Letter to IOL Labelers re: GUDID Submissions – July 10, 2015
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