Date: September 8, 2016
The following new items were added to the CDRH web pages on September 7, 2016. Previous CDRH New Items can be found on theCDRHNew Page.
- Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requests for Clinical Laboratory Improvement Amendments Categorization
- August 2016 PMA Approval List
- Federal Register: Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus; Availability
- September 7, 2016 MDUFA III Performance Report
- The FDA recommends against using screening tests for ovarian cancer screening: FDA Safety Communication
- Transcript posted for August 16, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee meeting