CDRHNew - News and Updates

CDRHNew - News and Updates

The following new items were added to the CDRH web pages on February 15, 2018. Previous CDRH New items can be found on the CDRH New webpage. Consumer Information on: Aptima HBV Quant assay - P170025 Direct-to-Patient Mammogram Results: It’s the Law Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN170073 added) Press Release: FDA expands treatment window for use of clot retrieval devices in certain stroke patients Federal Register: Pediatric Medical Device Development