March 8, 2023 FDA 21 CFR Part 7 vs. Part 806: What’s the Difference? And as you deliberate on the nature of your proposed field gesture, remember first that 21 CFR Part 806 is not the regulation for categorization, evaluation, or initiation of any recall. Instead, FDA intends Part 806 to be for assuring proper […]
That Advisory Notice Might be a Recall
March 8, 2023 That Advisory Notice Might be a Recall I received a question today wondering if user facilities should be notified to quarantine devices if a device safety issue is suspected. The answer is yes, but with great care. Specifically, if a device safety issue suspected with distributed units, then the manufacturer certainly […]
What if I Add an Expiration Date for Risk Reduction?
February 24, 2023 What if I Add an Expiration Date for Risk Reduction? If, to reduce risk, you are adding an expiration date to a medical device model for which previously-marketed units do not have such an expiration date, then, generally speaking, the governing regulatory authorities will reflexively suspect/assert that a recall might be […]
Recall Classification: EU MDR / IVDR
February 20, 2023 Recall Classification: EU MDR / IVDR Neither the EU MDR nor IVDR contain a formal risk-classification scheme for recalls. So in general, other jurisdictions’ (e.g., U.S. FDA, Health Canada) defined recall classification tiers are not a clear paradigm of the EU MDR/IVDR (yet the future finalization of the EUDAMED database might […]
Recall Classification: U.S. FDA
February 20, 2023 Recall Classification: U.S. FDA For the U.S. FDA, a risk-based approach is required for categorizing a recall; for planning and implementing a recall (e.g., to assure proper recall depth and effectiveness); for resolving the issues that caused the recall; for writing the recall notification, etc., etc. First, a proposed remedial […]
Recall Initiation in the U.S.
February 17, 2023 Recall Initiation in the U.S. In most cases, FIRMS initiate recalls rather than FDA: If U.S. recall trigger criteria are met, then FDA generally requires that FIRMS initiate recalls. FDA’s corresponding regulation is called “Firm-initiated recall” and is located at 21 CFR §7.46. See also FDA’s corresponding recent guidance document, […]
FDA 21 CFR Part 7 vs. Part 806: What’s the Difference?
January 26, 2023 FDA 21 CFR Part 7 vs. Part 806: What’s the Difference? The most succinct way I’ve seen FDA correlate 21 CFR Part 806 with 21 CFR Part 7 is by stating that Part 806 reports of corrections and removals are required for Part 7 Class I and Class II recalls, yet […]