Anon, if there is a device safety issue suspected, then yes, the manufacturer can certainly advise user facilities to immediately quarantine the product while the investigation and risk assessment are underway. And I like the logistics of your proposed approach. However, I've seen some prominent multinational medical device corporations advise to be VERY careful and aware that such a quarantine instruction and field action could be automatically considered by FDA to be a recall.
This seems in part to be because such a quarantine-and-investigate action could meet the "removal" and "inspection" qualifiers in FDA's recall definition when paired with a scenario where the underlying basis for such an action is consistent with FDA's triggers/criteria for "recall". In other words, FDA can consider firms to have initiated a recall even if the firm doesn't realize it at the time. I'd be curious to hear others' related experience on that aspect.
And as you deliberate on the nature of your proposed field gesture, remember first that 21 CFR Part 806 is not the regulation for categorization, evaluation, or initiation of any recall. Instead, FDA intends Part 806 to be for assuring proper reporting to FDA of certain recalls; specifically, class I and II recalls. FDA directly clarified this when it promulgated Part 806 after the agency received stakeholder confusion about the relationship between Part 806 corrections and removals vs. 21 CFR Part 7 recalls. 21 CFR Part 806 isn't triggered or invoked by sending a letter to your customers. Instead and ultimately, 21 CFR Part 7 governs firm-initiated recalls and FDA-"requested" recalls along with the associated customer notifications (while similarly, 21 CFR Part 810 governs FDA-mandated recalls). Again, Part 806 is not for initiation of any recall, nor for the related recall or other customer communication. Accordingly, be sure you first apply the appropriate event-triaging and planning (including customer notification) paradigms from Part 7 as a first step before tackling the separate task of deciding if a recall or safety alert is reportable to FDA under Part 806.
Remember also that firm-initiated recalls may not be reportable to FDA, in which cases the firm is responsible to decide whether the action is a recall. FDA may later scrutinize that decision (e.g., during routine GMP inspections) but nonetheless still leaves the onus on the firm to make the appropriate categorization in real-time.
Another important point to consider is that "safety alerts" as defined by FDA may or may not be a recall, and thus may or may not be reportable to FDA under Part 806. For example, FDA's internal operating procedure for this is that some safety alerts might just be safety alerts and/or market withdrawals (i.e., not necessarily reportable to the FDA). Accordingly, you should certainly NOT invoke Part 806 just because you've issued a safety alert. Instead, invoke Part 806 when Part 806 says to invoke Part 806.
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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.
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Original Message:
Sent: 07-Mar-2023 09:55
From: Dan O'Leary
Subject: Device Quarantine notification
Once you send out the letter to your customers, you have invoked the Part 806 Corrections and Removals regulation. (In ISO 13485:2016 this is called an Advisory Notice.)
The next step is to determine, under Part 806, whether the action is reportable to FDA or falls under one of exceptions. (From the description, I think it is reportable.)
There is a fine point here. You will send the initial letter to the user facilities telling them not to use the device (quarantine). You will send a subsequent letter to the user facilities telling what action to take with the devices in quarantine. It will be either a correction or a removal based on the Part 806 definitions. It doesn't become a recall until FDA makes the decision. They will tell you the recall class and other information such as the depth of recall.
If FDA decides it is a recall, you will make periodic reports to FDA until they tell you the recall is closed.
To answer your last question, the medical device safety alert is reportable to FDA under Part 806. Moreover, once you send out the initial letter to the user facilities, you should expect a copy will go to FDA within one week.
From the description, there is probably an associated complaint and a Part 803 Medical Device Report, MDR. Make sure it is up to date. Part 806 says you can report the correction and removal using the MDR form. However, the MDR form doesn't include all the information required by Part 806. Companies have received Warning Letters for following this path.
Lastly, you should expect an FDA Inspection within six months. It may not happen, but best to be prepared.<o:p></o:p>
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 07-Mar-2023 06:16
From: Anonymous Member
Subject: Device Quarantine notification
This message was posted by a user wishing to remain anonymous
Hi,
If there is a device safety issue suspected , can the manufacturer advise the devices to be quarantined immediately at the user facilities , while the investigation and risk assessment are underway ?
Is the below chronology correct ?
- Advice for device quarantine at the user facilities
- Completion of investigation and risk assessment
- Once the issue is confirmed to be a safety issue , notify health authorities , agree on the recall communication
- Issue the recall communication to the users
- Conduct the recall actions.
Is a medical device safety alert reportable to FDA ?
Thanks