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, they're likely to under-report field actions by misinterpreting Part 806.
When is reporting voluntary vs. mandatory? What characteristics of the recall must you consider when making that determination? When there is a conflict, which rule applies? Discover the answers — and more — in a new management report from FDAnews.
This report outlines four easy-to-follow steps to determine which regulation applies ... or when neither applies and no reporting is necessary. You’ll learn:
- Differences in the requirements for all recalls, vs. those specific to devices
- How to review existing recall programs, identify gaps and fix them
- Best practices to ensure you are not reporting improperly under Part 806, including a decision-making flow chart
- Plain-English explanations of what the two conflicting regs actually say
- And much more
Part 806 gets particular attention in this report. Many devicemakers are not clear on how Part 806 aligns with general recall requirements under Part 7, as well as standing recall guidance. Getting this wrong can lead to under-reporting device recalls ... and an unwelcome slap on the wrist.
Don’t risk that in your operation — not when a simple four-step procedure can make this problem go away for good. Order your copies of Medical Device Recall Reporting: Four Steps to Compliance with 21 CFR Parts 7 and 806 ... now.
Medical Device Recall Reporting: Four Steps to Compliance with 21 CFR Parts 7 and 806 is available in print or PDF format for $377.
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