CDRH New Update

The following new items were added to the CDRH web pages on January 16, 2018. Previous CDRH New items can be found on the CDRH New webpage. Public Workshop - Accreditation Scheme for Conformity Assessment (ASCA) of Medical Devices to FDA-Recognized Standards, May 22-23, 2018 Webcast and Presentation Slides added to Public Workshop - Self-Collection Devices for Pap Test, January 11, 2018 Press Release: Statement from FDA Commissioner Scott Gottlieb, M.D., in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review Federal Register: Internal Agency Review of Decisions; Requests for Supervisory Review of Certain Decisions Made by Center for Devices and Radiological Health