CDRH New Update

The following new items were added to the CDRH web pages on March 7, 2018. Previous CDRH Newitems can be found on the CDRH New webpage. Essure Permanent Birth Control: FDA Activities Press Release: FDA authorizes, with special controls, direct-to-consumer test that reports three mutations in the BRCA breast cancer genes Press Release: Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA activities related to the ongoing post-market review of Essure and FDA’s commitment to keep women informed Federal Register: Study Design Considerations for Devices Including Digital Health Technologies for Sleep Disordered Breathing in Adults Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN160020 added)