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 not for Part 7 Class III recalls.  Specifically, manufacturers and importers are required to make a Part 806 report to FDA of any correction or removal of a medical device(s) if the correction or removal was initiated to reduce a risk to health posed by the device or to remedy a violation of the act caused by the device which may present a risk to health.

Having addressed when Part 806 becomes applicable, let’s now focus more on when Part 7 becomes applicable.  Specifically, Part 7 has two distinct purposes:

• Regulation of FDA’s own internal practices and procedures applicable to regulatory actions (e.g., recalls) initiated by (i.e., forced by) the FDA in urgent situations as an alternative to an FDA-initiated court action.

• “Guidance” for manufacturers and distributors for their “voluntary” removal or correction (i.e., their voluntary “recall” or “market withdrawal”) of marketed products so that such voluntary actions are discharged in a way that is effective in FDA’s eyes.

In practice, if FDA detects and believes that a product needs to be recalled for protection of public health, then the agency will “suggest” to a firm that the firm should “consider” recalling the device.  Let me translate this: This means the firm is essentially being ordered by FDA to recall the device, or else FDA will force the recall and will, if needed, resort to legal actions against the firm.  This comes from the essence of the official definition of “recall”: A firm’s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure (e.g., if the firm doesn’t voluntarily cooperate) [interpretive emphasis added].

So, ultimately, Part 7’s “voluntary” scope as applied to manufacturers and importers isn’t really voluntary, as those firms would alternatively be forced by the agency.

Ultimately, the most efficient and effective way for a firm to put a recall in its rear-view mirror and get back to business is by executing and documenting the recall following the recall steps outlined by Part 7 while being sure to report via Part 806 those recalls that meet the aforementioned Part 806 reporting criteria.  For example, when I do a Part 806 report for a Class I or II recall, there are certain section 806.10(c) elements [e.g., subsections 7, 8, 9, 12, etc.] that are addressed via the section 7.41, 7.42, and 7.49 health hazard evaluation, recall strategy, and recall communications.  Same thing, by the way, for the non-reportable 806.20 corrections or removals (e.g., Part 7 Class III recalls and market withdrawals).

For any lingering questions about the definitions, I’ll expand on the aforesaid “recall” definition by explaining that all recalls are either a correction or removal, but not all corrections or removals are recalls.  The classic example of this is a “market withdrawal”, which means a correction or removal of a distributed product which involves a minor violation that would not be subject to FDA legal action or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc.

Note also that Field Safety Corrective Action (FSCA) is not a concept directly recognized by the U.S. FDA. Instead, FSCA is a term of Europe’s medical device regulations.  This is important to note because FSCA (and also Europe’s definition of “recall”).