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 reporting to FDA of certain recalls; specifically, class I and II recalls. FDA directly clarified this when it promulgated Part 806 after the agency received stakeholder confusion about the relationship between Part 806 corrections and removals vs. 21 CFR Part 7 recalls.

Indeed, 21 CFR Part 806 isn’t triggered or invoked by sending a letter to your customers.  Instead and ultimately, 21 CFR Part 7 governs firm-initiated recalls and FDA-“requested” recalls along with the associated customer notifications (while similarly, 21 CFR Part 810 governs FDA-mandated recalls).  Again, Part 806 is not for initiation of any recall, nor for the related recall or other customer communication.  Accordingly, be sure you first apply the appropriate event-triaging and planning (including customer notification) paradigms from Part 7 as a first step before tackling the separate task of deciding if a recall or safety alert is reportable to FDA under Part 806.

Remember also that firm-initiated recalls may not actually be reportable to FDA, in which cases the firm is responsible to decide whether the action is a recall.  FDA may later scrutinize that decision (e.g., during routine GMP inspections), but nonetheless still leaves the onus on the firm to make the appropriate categorization in real-time.

Another important point to consider is that “safety alerts” as defined by FDA may or may not be a recall, and thus may or may not be reportable to FDA under Part 806.  For example, FDA’s internal operating procedure for this is that some safety alerts might just be safety alerts and/or market withdrawals (i.e., not necessarily reportable to the FDA).  Accordingly, you should certainly NOT invoke Part 806 just because you’ve issued a safety alert.  Instead, invoke Part 806 when Part 806 says to invoke Part 806.