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Home » Store » Webinar Recordings » Part 806 Reports: When to Submit? - Webinar Recording/Transcript

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Part 806 Reports: When to Submit? - Webinar Recording/Transcript

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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. 

Presentation Takeaways:

  • 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.

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