MDR Adverse Event Codes for Devicemakers - Webinar Recording/Transcript
MDR Adverse Event Codes for Devicemakers
What devicemakers know is that MDR reporting is slated to change, with the old coding system going obsolete and new challenges arising to completion of Form 3500A.
What many devicemakers still don’t know — but need to — is that the FDA is ready to assist you, with a free downloadable tool known as eSubmitter.
All you gotta do is figure out how to use it … before the codes change.
And that’s where FDAnews comes in. Dan O’Leary, one of our top-rated presenters, introduces you to the new coding regimen and walks you through eSubmitter’s twists, turns and tricks. In a fast-paced 90 minutes, you’ll discover:
- Criteria for a mandatory medical device report
- Required records and their content
- The reporting system and associated acknowledgements
- When codes apply in eSubmitter
- The IMDRF harmonization plan: Which parts the FDA has adopted
- Selecting the appropriate codes
- Transition dates: Avoiding FDA rejection of obsolete codes
- And MUCH more!
Don’t put off figuring out eMDR submission and risk blowing the deadline. Get ready for implementation now, well ahead of the effective date, and gain crucial background that helps you implement the new coding system without a hitch.