CDRH New Update

CDRHNew

Date: October 22, 2015

The following new items were added to the CDRH web pages on October 21, 2015. Previous CDRH New Items can be found on theCDRHNew Page.

• Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Center for Devices and Radiological Health Appeals Processes
• Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Cover Sheet, Form FDA 3601
• Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Inspection by Accredited Persons Program
• CDRH Industry Basics Workshop - Purchasing Controls & Process Validation - November 4, 2015
• Federal Register: Manufacturing Site Change Supplements: Content and Submission; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
• Federal Register: Medical Devices; Cardiovascular Devices; Classification of the Coronary Vascular Physiologic Simulation Software Device