CDRH New - April 27, 2022

If your email program has trouble displaying this email, view as a webpage. April 27, 2022 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on April 26, 2022. To view listings for other dates, see CDRH New - News and Updates. Class I Recall: Medtronic Recalls Harmony Delivery Catheter, Part of Transcatheter Pulmonary Valve (TPV) System, for Risk of Capsule Break During Use Medical Device User Fee Amendments 2023 (MDUFA V) (Updated - Industry Discussions on MDUFA V Reauthorization) FDA-Industry MDUFA V Reauthorization Meeting, March 7, 2022 FDA-Industry MDUFA V Reauthorization Meeting, March 3, 2022 FDA-Industry MDUFA V Reauthorization Meeting, March 2, 2022 FDA-Industry MDUFA V Reauthorization Meeting, February 24, 2022 FDA-Industry MDUFA V Reauthorization Meeting, February 22, 2022 Medical Device Development Tools (MDDT) (Updated) New tool:  FACE-Q Aesthetics Transcripts added to Virtual Public Workshop - 3D Printing in Hospitals: Veteran's Health Administration's Experiences in Point of Care 3D Printing of Device and Implementing a Quality Management System - March 16 -17, 2022

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