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.

  • Quality/QSR
  • Regulatory affairs
  • Inspections/audits
  • Postmarket safety
  • Commercial operations
  • Legal counsel

Pamela Forrest Esq., a Partner in the Food, Drug, and Device Practice at Covington & Burling, claims 25 years of experience advising medical device clients on FDA regulatory issues including premarket notification, premarket approval, product recalls, Medical Device Reporting (MDR), Quality System Regulation (QSR) compliance, establishment registration and device listing, labeling and promotion, import/export issues, and clinical trial requirements. She is a frequent writer and speaker on FDA device regulation and has testified before state legislative committees regarding device legal and regulatory issues.