CDRH New - October 29, 2019

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on October 28, 2019. To view listings for other dates, see CDRH New - News and Updates.

FDA Fact Sheet: The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Draft Guidance (September 2019) (PDF - 194KB) Update on Risk of Type III Endoleaks with Use of Endologix AFX Endovascular AAA Graft Systems: FDA Safety Communication FDA In Brief: FDA provides new information on risks for patients with endovascular grafts based on real-world data as the agency continues to monitor postmarket safety of these devices Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN140016, DEN180013, DEN180026, DEN180041, DEN180047, DEN180059 and DEN180060 added) Webinar: Collaborative Communities - October 29, 2019 Federal Register: Clinical Chemistry and Clinical Toxicology Devices; Classification of the Continuous Glucose Monitor Data Management System