Mislabeling - Consider this an FDA notified recall? CFR 806.10

J

Jkc3usc12

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#1
#1
So i have read CFR 806.10 and everything is tied to

(1) To reduce a risk to health posed by the device; or
(2) To remedy a violation of the act caused by the device which may present a risk to health unless the information has already been provided as set forth in paragraph (f) of this section or the corrective or removal action is exempt from the reporting requirements under 806.1(b).

The mislabeling we have poses no risk. Since this labeling error does not meet the requirements of 1 or 2 above would we need to notify the FDA?
 
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William55401

William55401

Quite Involved in Discussions
#2
#2
I pulled the following quote from FDA guidance related to recalls, corrections, and removals. It sounds like you may want to dig deeper before making a decision not to notify.

"......and misbranded products where no health hazard exists are still in violation of the law and should be recalled"

Follow the URL and search on "misbranded"
Guidance for Industry: Product Recalls, Including Removals and Correc

Suggest you read the following to learn more about what is considered misbranding in the device world.
General Controls for Medical Devices

Can you share more detail without disclosing your org and product?
 
Last edited:
Watchcat

Watchcat

Trusted Information Resource
#3
#3
Sec. 806.10 Reports of corrections and removals.

(a) Each device manufacturer or importer shall submit a written report to FDA of any correction or removal of a device initiated by such manufacturer or importer if the correction or removal was initiated:

(1) To reduce a risk to health posed by the device; or

(2) To remedy a violation of the act caused by the device which may present a risk to health unless the information has already been provided as set forth in paragraph (f) of this section or the corrective or removal action is exempt from the reporting requirements under 806.1(b).

If you do not think the mislabeling poses any risk to health, it seems clear to me that you do not need to report it. However, I would prepare a memo to file explaining your rationale for concluding that it poses no risk. In that document, I would also clarify why you decided to recall it, given that you didn't think it posed a risk to health.
 
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