Part 806 Reports: When to Submit? - Webinar Recording/Transcript
Part 806 Reports: When to Submit?: Is It a Device Recall … or Product Enhancement?
Devicemaker alert: The FDA is on the lookout for Part 806 violations and will deal out appropriate sanctions for violation. Can you tell the difference between a device recall and a product enhancement?
Too many devicemakers would have to answer ‘no’ … and face, at the worst, a product seizure. Make sure that doesn’t happen to you by registering now for a new FDAnews webinar on Part 806 basics.
For your guide we’ve tapped Pamela Forrest Esq., a top FDA expert from the noted Washington law firm of Covington & Burling. She’ll take you on a whirlwind tour of 21 C.F.R. 806 including the subtleties that can make the difference between a warning letter and a clean bill of health.
- 21 C.F.R. Part 806: Nuances of the regulation, when to report a recall
- Recall-specific terms: How recalls differ from enhancements
- Part 806 pitfalls: Handling different classes of device recalls
- Bad things that can happen: Enforcement actions, liability and more
- Product seizures: They’re among the worst of bad things
Part 806 can be confusing. What once was a product enhancement now may be considered a recall … and, sometimes, neither enhancement nor recall. This is the moment to figure it all out. Join us by registering today.