CDRH New Update

CDRHNew

Date: September 7, 2016

The following new items were added to the CDRH web pages on September 6, 2016. Previous CDRH New Items can be found on theCDRHNew Page.

• Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in the Medical Device Fellowship Program
• Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications
• Class I Medical Device Recall: Cook Medical Recalls Roadrunner® UniGlide® Hydrophilic Wire Guide Because of Potential Coating Contamination
• Mammography Facility Adverse Event and Action Report - September 6, 2016: AdvancedTech Breast Imaging Specialists, LLC
• UDI Extension Letter to Device Labelers - September 6, 2016