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, ‘Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C, Guidance for Industry and FDA Staff‘.  That guidance covers things like:

• • a firm’s creation of internal procedures for initiating recalls,

  • an official FDA definition of “Initiation of a Recall“, the scope of which is focused solely on the firm,

  • tactics to help firms initiate recalls efficiently and properly,

  • allowing firms to initiate a recall even before its investigation is finished, and even before FDA finishes its agency review (if FDA was notified) of the scenario,

  • making company decisions about recall initiation independent of FDA, and

  • reiterating that firms are just “requested” to notify FDA bout firm-initiated recalls unless otherwise required by other FDA regulations (see next header below in this post).

• FDA has an FAQ, “Who recalls medical devices?“.  FDA’s answer: “…In most cases, a company (manufacturer, distributor, or other responsible party) recalls a medical device on its own (voluntarily)…“

• See also the attached training slides from FDA, guiding firms on firms’ recall-initiation deliberations.

Certain firm-initiated recalls (i.e., Class III recalls) of medical devices aren’t required to be reported to FDA; thus they can be initiated and happen without FDA’s involvement:

• First, 21 CFR Part 806 is not the regulation for initiation of firm-initiated recalls, nor for initiation of any other recall.  Instead, FDA intends Part 806 to be for assuring proper reporting to FDA of certain recalls; specifically, class I and II recalls. FDA specifically clarified this when it promulgated Part 806 after FDA received stakeholder confusion about the relationship between Part 806 corrections and removals vs. Part 7 recalls.

• 21 CFR Part 7 governs firm-initiated recalls and FDA-“requested” recalls, while Part 810 governs FDA-mandated recalls.  Again, Part 806 is not for initiation of any recall.

• The issue of reporting firm-initiated Class III recalls to FDA can be tricky.  But ultimately, when FDA promulgated aforesaid §7.46 (Firm-initiated recalls) after receiving stakeholder push-back, the agency conceded that notifying FDA about firm-initiated recalls is not required unless required by other FDA regulations (e.g., Part 806 regarding class I and II recalls).  FDA revised proposed §7.46 accordingly during promulgation by revising it to say that firms are only “requested” to notify FDA about firm-initiated recalls.  And when FDA later promulgated Part 806 (to require FDA notification about class I and II recalls), FDA emphasized that class III recalls aren’t reportable to FDA.

• That said, FDA does strongly urge firms to voluntarily report their non-reportable (i.e., class III) firm-initiated recalls.  In a September 2020 FDA webpage narrative, FDA even goes so far as to state that firms are “required to immediately notify” FDA of firm-initiated recalls of violative devices.  But that broad stroke doesn’t align with the aforesaid actual regulatory requirements.  Accordingly, I consider that webpage narrative to be an overreach that goes beyond the regulatory requirement.  Indeed, in the aforesaid attached guidance from 2022, FDA reverts to the “requested” language.

• There can be benefits of voluntary notifications of recall to FDA, but there can also be pitfalls.  Each case of potential voluntary reporting needs to be pondered on its own merit.

ALL recalls are either corrections or removals.  But not all corrections or removals are recalls.