Part 806 Device Recalls What You Should Know to Avoid Under-Reporting
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Damned if you do, damned if you don’t. That’s the feeling many have in trying to comply with recalls related to 21 CFR Part 7 and 21 CFR Part 806.
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.
On April 12 Gordon Richman of EduQuest clarified the critical differences. In this in-depth audio CD/transcript, 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.