CDRH New Update

The following new items were added to the CDRH web pages on March 19, 2019. Previous CDRH Newitems can be found on the CDRH New webpage. Meeting materials posted for March 21, 2019 Neurological Devices Panel of the Medical Devices Advisory Committee meeting CLIA Waiver by Application Decision Summaries Press Release: FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements