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MDUFA IV: Accessing and Using Real-World and Postmarket Data for Regulatory Decision-Making

A video report for the October 27, 2020 virtual public meeting on Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027
https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/virtual-public-meeting-medical-device-user-fee-amendments-fiscal-years-2023-through-2027-10272020

Accessing and Using Real-World and Postmarket Data for Regulatory Decision Making
Daniel Caños, PhD
Director, Office of Clinical Evidence and Analysis
Office of Product Evaluation and Quality, CDRH

Voluntary Malfunction Summary Reporting Program
CAPT Sean Boyd
Director, Office of Regulatory Programs
Office of Product Evaluation and Quality, CDRH

Overview of Signal Management at CDRH
Ron Yustein
Associate Director for Postmarket Programs
Office of Product Evaluation and Quality, CDRH

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