Medical Device Voluntary Malfunction Disclosure Regulation - Webinar Recording/Transcript
Medical Device Voluntary Malfunction Disclosure Regulation: Are You Up to Date on the Latest Developments?
The Voluntary Malfunction Summary Reporting Program was finalized in August 2018 and lets manufacturers report certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis instead of the typical 30 days for each individual report.
Over the course of 90 fast-paced minutes, Stephanie Resnik and Christopher Hanson — associates at Covington & Burling LLP, Washington, DC — will discuss which products are covered, how the program will help increase efficiency and whether it makes sense to take part in the program. You’ll learn:
- Background of the Voluntary Malfunction Summary Reporting Program including:
- Origins of the program
- FDA’s intentions in establishing the program
- Types of manufacturers, devices, and events eligible to participate in the program
- How the Voluntary Malfunction Summary Reporting Program differs from individual malfunction reporting
- Benefits to device manufacturers including the efficiency advantages offered by the program
- Conditions under which the program is not available to manufacturers
- And much more…
Join us and discover the advantages of participating in the Voluntary Malfunction Summary Reporting Program.