Part 806 Device Recalls What You Should Know to Avoid Under-Reporting
Product Details
Under 21 CFR Part 7, you are requested to report corrections or removals to your FDA District Recall Coordinator promptly. But under 21 CFR Part 806, you are required to report within 10 business days after initiating such corrections or removals.
Not only are devicemakers running afoul of the FDA on this point, but they're likely to under-report field actions by misinterpreting CFR Title Part 806.
While Part 806 requires you to report recalls, it also has some exemptions. But devicemakers are finding it confusing to decide when and how to apply the exemption.
Many device companies are getting themselves into trouble because they don't fully understand how to reconcile the FDA's general recall requirements under Part 806 and the enforcement provisions of Part 7. Can they really be seamlessly integrated?
Yes they can. And FDAnews has brought in one of the industry’s top experts to help.
Join us on Thursday, April 12, when Gordon Richman of EduQuest clarifies the critical differences. In this in-depth webinar, you'll discover:
- How to review your existing programs, find and fix the faulty gaps
- The differences in the requirements for medical device versus drug/biologics recalls
- Recent FDA citations and a workable framework if you're new to these issues
- The best practices for revamping your operations to comply properly with reporting requirements under Part 806
- How to drive your medical device recall process to ensure that it is evaluating the right criteria and answering the right questions
- Legal and practical explanations of the CFR Title 21 Part 7 Enforcement Policy and CFR Title 21 Part 806
- And more.
As with every FDAnews webinar, Part 806 Device Recalls is easily accessible from any computer screen on the day and time of the event.
You'll not only hear a world-class authority demystify these issues, but you can submit your own questions to Mr. Richman by email for his expert advice and get your answers by the end of the session.
You pay only one low registration fee per facility, regardless of how many participate — so spread the word to anyone in your organization with a vested interest in this topic.
With our money-saving registration policy and Mr. Richman's respected expertise, you have every reason to take advantage of this timely webinar. Register now.