Regulatory Open Forum

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.

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.

Yet 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.

------------------------------
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.

Just corrected a typo and clarified some statements; be sure to read the latest.

------------------------------
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 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.

------------------------------
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.

Hey,

The recalling company will have to provide the "burden of proof" that all reasonable efforts have been made to remove the violative product from the market (I always used the golden three-tries rule and documented each communication).  The recalling firm should also regularly contact the FDA field coordinator to indicate any issues, the volume of product in the market, quarantine, etc.  I would also ensure I provided document communication to them as well. 

------------------------------
Zillery Fortner
Product Advisor QA/RA Life Science
Florence KY
United States
------------------------------

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.

I'd like to chime in on this one.

Your company cannot initiate a Class 3 recall because only FDA can initiate a recall (see Part 7). Instead the device manufacturer initiates a correction or removal. The regulation is in Part 806. As part of the implementation, the device manufacturer determines if the correction or recall is reportable to FDA. Then, FDA determines if it is a recall and, if so, assigns the recall class.

Another common confusion is whether a "recall" is a correction or a removal. I've worked with companies that think recall and removal are synonymous, i.e., they require removal of the device. In many cases a correction is adequate without removal.

In this case, the customer reviewed their inventory and did not find it nonconforming; then there is no reason for them to remove it. You have the documentation to support their action, so you are done. Put it in your file in case the question comes up at your next FDA Inspection.

Also, be thankful that you have this good customer who is willing to review the inventory and report the results to you.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------

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.

In most cases, FIRMS initiate recalls rather than FDA:

• If U.S. recall trigger criteria are met, then FDA generally requires that FIRMS initiate recalls. FDA's corresponding regulation is called "Firm-initiated recall" and is located at 21 CFR 7.46.

• See also FDA's corresponding recent guidance document attached, 'Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C, Guidance for Industry and FDA Staff'.  That guidance covers things like:

• • a firm's creation of internal procedures for initiating recalls,
  • an official FDA definition of "Initiation of a Recall", the scope of which is focused solely on the firm,
  • tactics to help firms initiate recalls efficiently and properly,
  • allowing firms to initiate a recall even before its investigation is finished, and even before FDA finishes its agency review (if FDA was notified) of the scenario, 
  • making company decisions about recall initiation independent of FDA, and
  • reiterating that firms are just "requested" to notify FDA bout firm-initiated recalls unless otherwise required by other FDA regulations (see next header below in this post).

• FDA has an FAQ, "Who recalls medical devices?".  FDA's answer: "...In most cases, a company (manufacturer, distributor, or other responsible party) recalls a medical device on its own (voluntarily)..."

• See also the attached training slides from FDA, guiding firms on firms' recall-initiation deliberations.

Certain firm-initiated recalls (i.e., Class III recalls) of medical devices aren't required to be reported to FDA; thus they can be initiated and happen without FDA's involvement:

• First, 21 CFR Part 806 is not the regulation for initiation of firm-initiated recalls, nor for initiation of any other recall.  Instead, FDA intends Part 806 to be for assuring proper reporting to FDA of certain recalls; specifically, class I and II recalls. FDA specifically clarified this when it promulgated Part 806 after FDA received stakeholder confusion about the relationship between Part 806 corrections and removals vs. Part 7 recalls.

• 21 CFR Part 7 governs firm-initiated recalls and FDA-"requested" recalls, while Part 810 governs FDA-mandated recalls.  Again, Part 806 is not for initiation of any recall.

• The issue of reporting firm-initiated Class III recalls to FDA can be tricky.  But ultimately, when FDA promulgated aforesaid 7.46 (Firm-initiated recalls) after receiving stakeholder push-back, the agency conceded that notifying FDA about firm-initiated recalls is not required unless required by other FDA regulations (e.g., Part 806 regarding class I and II recalls).  FDA revised proposed 7.46 accordingly during promulgation by revising it to say that firms are only "requested" to notify FDA about firm-initiated recalls.  And when FDA later promulgated Part 806 (to require FDA notification about class I and II recalls), FDA emphasized that class III recalls aren't reportable to FDA.

• That said, FDA does strongly urge firms to voluntarily report their non-reportable (i.e., class III) firm-initiated recalls.  In a September 2020 FDA webpage narrative, FDA even goes so far as to state that firms are "required to immediately notify" FDA of firm-initiated recalls of violative devices.  But that broad stroke doesn't align with the aforesaid actual regulatory requirements.  Accordingly, I consider that webpage narrative to be an overreach that goes beyond the regulatory requirement.  Indeed, in the aforesaid attached guidance from 2022, FDA reverts to the "requested" language.

• There can be benefits of voluntary notifications of recall to FDA, but there can also be pitfalls.  Each case of potential voluntary reporting needs to be pondered on its own merit.

ALL recalls are either corrections or removals.  But not all corrections or removals are recalls.

------------------------------
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: 17-Feb-2023 10:46
From: Dan O'Leary
Subject: Med Device Recall customer responsibility

I'd like to chime in on this one.

Your company cannot initiate a Class 3 recall because only FDA can initiate a recall (see Part 7). Instead the device manufacturer initiates a correction or removal. The regulation is in Part 806. As part of the implementation, the device manufacturer determines if the correction or recall is reportable to FDA. Then, FDA determines if it is a recall and, if so, assigns the recall class.

Another common confusion is whether a "recall" is a correction or a removal. I've worked with companies that think recall and removal are synonymous, i.e., they require removal of the device. In many cases a correction is adequate without removal.

In this case, the customer reviewed their inventory and did not find it nonconforming; then there is no reason for them to remove it. You have the documentation to support their action, so you are done. Put it in your file in case the question comes up at your next FDA Inspection.

Also, be thankful that you have this good customer who is willing to review the inventory and report the results to you.<o:p></o:p>

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States

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.