Just corrected a typo and clarified some statements; be sure to read the latest.
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
Original Message:
Sent: 16-Feb-2023 15:15
From: Kevin Randall
Subject: Med Device Recall customer responsibility
For a U.S. medical device class 3 recall (or any U.S. medical device recall class for that matter), a customer's lack of cooperation is linked to the targeted 21 CFR 7.42(b)(3) recall effectiveness level (i.e., Levels A through E), and in turn to the actual effectiveness level ultimately achieved and reported in the 21 CFR 7.53(b) status report. As far as I know, FDA guidance on recall status reports doesn't offer much more than a regurgitation of the basic requirement to notify FDA of the achieved effectiveness level.
If FDA has a concern about uncooperative respondents, then FDA will work dynamically with the recalling firm, and may even contact the customer itself, commensurate with risk, to assure public health is properly safeguarded for the case in question.
Remember that, as a general rule per 21 CFR Part 806, a class 3 recall isn't generally required to be reported to the FDA. Thus, there would be no recall status report submitted to FDA unless the recalling firm has voluntarily decided to go above-and-beyond the Part 806 regulatory requirements. For an unreportable recall, the uncooperative customer scenario needs to be described, and a risk-based assessment added, in the 806.20 record of unreportable recall, specifically in subsection (b)(4) thereunder.
In addition to the FDA requirements, you should also discuss the uncooperative customer with general counsel to assure any associated liabilities are suitably managed. I have seen such instances involve sending a legal indemnity request to such customers.
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
Original Message:
Sent: 16-Feb-2023 13:36
From: Anonymous Member
Subject: Med Device Recall customer responsibility
This message was posted by a user wishing to remain anonymous
Hello All!
My company has initiated a class 3 recall (lowest risk to health). We have sent out notifications to our customers along with a reconciliation form. A customer of ours has sent the form back with notice that the company did not find defects to the products and will NOT be sending the recalled affected lot back to us.
What is our requirement or responsibilities to the FDA other than the reporting update. Is there a specific guidance I can review to make sure that we are following what is expected.
Thanks in advance.