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Part 806 Device Recalls <br /><i>What You Should Know to Avoid Under-Reporting</i>
Part 806 Device Recalls What You Should Know to Avoid Under-Reporting
Audio CD/Transcript - April 12, 2012 <p>
The Audio CD/Transcript will be shipped the week of May 7, 2012.
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.