Medical Device Recall or Product Enhancement? - Webinar CD/Transcript
Medical Device Recall or Product Enhancement?: Understanding When to Submit a Part 806
Based on the FDA’s most recent recall guidance, devicemakers now have to wonder if their product enhancements are:
- An acceptable product enhancement
- A recall
- A product enhancement that’s now considered a recall
- Or neither a product enhancement nor a recall
Unclear on how your current or future product enhancements might be viewed by FDA? This webinar cd and transcript explains the differences.
In 2013 the FDA issued draft guidance (Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements) to explain when a product enhancement is really just a product enhancement and when a product enhancement actually qualifies as a recall.
The FDA stated that if your product fails any of these tests you need to submit a Part 806 report:
- Fails to perform as intended or fails to meet any specification
- Labeling that is false, misleading, or otherwise inaccurate
- Device is out of compliance with FDA regulations
The guidance also makes clear that if you make any product enhancements intended to reduce a risk to health — even if the reason is human error — you have committed a recall.
But the determination whether an enhancement reduces a risk to health is not always easy.
So what about any enhancements you are currently making — or considering? Are you sure they are not recalls? And if so, do you know what you need to do?
FDAnews teamed up with noted recall specialists Neil O’Flaherty and Casper (Cap) Uldriks of Olsson Frank Weeda Terman Matz to clear up your confusion.