Regulatory Open Forum

Hi All,

I have seen many discussions that pertains to recalls of medical device with the FDA. I am still having a hard time understanding the difference between 21 CFR 806 vs 21 CFR 7.

My lack of understanding is when does each become applicable. To me the definition of correction and removal sounds the same as recall and so CFR 806 covers the requirements?

If every issue in the filed for a medical device manufacturers is a correction and removal, when will it possibly be that the manufacturer has to abide by CFR 7? I understand that CFR 7 is voluntary recall, but there is a section that talks about "firm-initiated recall", when is this applicable? I feel like both the class I and II recall falls under CFR 806 and class II is not required to be reported to the FDA. Can someone help me understand, if possible with examples, as to when CFR 7 would be applicable to medical device manufacturer?

Thank you all.

Hi All,

I have seen many discussions that pertains to recalls of medical device with the FDA. I am still having a hard time understanding the difference between 21 CFR 806 vs 21 CFR 7.

My lack of understanding is when does each become applicable. To me the definition of correction and removal sounds the same as recall and so CFR 806 covers the requirements?

If every issue in the filed for a medical device manufacturers is a correction and removal, when will it possibly be that the manufacturer has to abide by CFR 7? I understand that CFR 7 is voluntary recall, but there is a section that talks about "firm-initiated recall", when is this applicable? I feel like both the class I and II recall falls under CFR 806 and class II is not required to be reported to the FDA. Can someone help me understand, if possible with examples, as to when CFR 7 would be applicable to medical device manufacturer?

Thank you all.

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 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 your 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.

Hi All,

I have seen many discussions that pertains to recalls of medical device with the FDA. I am still having a hard time understanding the difference between 21 CFR 806 vs 21 CFR 7.

My lack of understanding is when does each become applicable. To me the definition of correction and removal sounds the same as recall and so CFR 806 covers the requirements?

If every issue in the filed for a medical device manufacturers is a correction and removal, when will it possibly be that the manufacturer has to abide by CFR 7? I understand that CFR 7 is voluntary recall, but there is a section that talks about "firm-initiated recall", when is this applicable? I feel like both the class I and II recall falls under CFR 806 and class II is not required to be reported to the FDA. Can someone help me understand, if possible with examples, as to when CFR 7 would be applicable to medical device manufacturer?

Thank you all.

Hi All,

I have seen many discussions that pertains to recalls of medical device with the FDA. I am still having a hard time understanding the difference between 21 CFR 806 vs 21 CFR 7.

My lack of understanding is when does each become applicable. To me the definition of correction and removal sounds the same as recall and so CFR 806 covers the requirements?

If every issue in the filed for a medical device manufacturers is a correction and removal, when will it possibly be that the manufacturer has to abide by CFR 7? I understand that CFR 7 is voluntary recall, but there is a section that talks about "firm-initiated recall", when is this applicable? I feel like both the class I and II recall falls under CFR 806 and class II is not required to be reported to the FDA. Can someone help me understand, if possible with examples, as to when CFR 7 would be applicable to medical device manufacturer?

Thank you all.