This second session of the FDA presentations at ASLMS will expand on how devices are regulated by FDA after they are cleared or approved for marketing, including how adverse events (medical device reports, or MDR) are followed to identify safety concerns and how Unique Device Identifiers, which are required for all medical devices, contribute to safe distribution, use, reporting and when needed recall of devices. This session will also address drugs used for disorders presented at ASLMS.
Presentations:
7:00 AM – 7:08 AM EDT
TPLC Advisory Program
Faculty: Kimberly Ferlin
7:08 AM – 7:16 AM EDT
Adverse Events and Medical Device Reporting
Faculty: Yongqing Chen, PhD
7:16 AM – 7:24 AM EDT
Unique Device Identifiers (UDI): A Primer for Clinicians and Manufacturers
Faculty: Thelma Valdes, PhD
7:24 AM – 7:32 AM EDT
Regulation of Drugs and Combination Drug-Device Products
