Regulatory Open Forum

There are some recent posts about recall authority and the distinction between mandatory and voluntary recalls. I recently read "Use of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration's 510(k) Pathway and Risk of Subsequent Recalls" by Kadakia et al in the Journal of the American Medical Association.

The article says, "Voluntary, manufacturer initiated recalls are the usual approach for medical device recalls, with the FDA exercising its recall power only 3 times between 1990 and 2010" citing the source as Institute of Medicine. Medical Devices and the Public's Health: the FDA 510(k) Clearance Process at 35 Years. The National Academies Press; 2011.

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

My own approach over the years is there was no such thing as a "mandatory" recall which would be made by FDA.  For me recalls were always voluntary ... even though FDA could strongly (and strongly) recommend (or request) a recall be performed by a medical devices manufacturer.  Though few years someone corrected me that according to the FD&C Act, US FDA can actually require companies to perform mandatory recalls, but I believe these are very, very rare (and this is just not medical devices, but biologics, blood products, drug products, and tobacco as well).  Also from my awareness if US FDA is mandating a company to conduct a recall - there are usually many other activities going on such as leading into injunctions and/or prohibitive bans for the product.  So I think doing a mandatory recall by FDA is probably the least of worries a company would be facing.  But I think generally, 99% of the time recalls would be "voluntary" whether by the company or suggested by an investigator.  As an example, I have been in FDA inspections where the investigator would never say a recall needs to be done, but they would usually say something like, "This really should have been a recall ..." suggesting to the company something they should have done.  They would never come out specifically stating a recall needs to be done, but leaves it up to the company to take care of the instance themselves.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 17-Mar-2023 10:50
From: Dan O'Leary
Subject: Device Recalls – Mandatory vs Voluntary

There are some recent posts about recall authority and the distinction between mandatory and voluntary recalls. I recently read "Use of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration's 510(k) Pathway and Risk of Subsequent Recalls" by Kadakia et al in the Journal of the American Medical Association.

The article says, "Voluntary, manufacturer initiated recalls are the usual approach for medical device recalls, with the FDA exercising its recall power only 3 times between 1990 and 2010" citing the source as Institute of Medicine. Medical Devices and the Public's Health: the FDA 510(k) Clearance Process at 35 Years. The National Academies Press; 2011.<o:p></o:p>

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Dan O'Leary CQA, CQE
Swanzey NH
United States
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Here are links to some prior Forum discussions giving deeper insights on the matter of mandatory vs. voluntary recalls:

• https://connect.raps.org/discussion/med-device-recall-customer-responsibility#bm61338aa9-f35a-44cf-b00a-0186602da4c7
• https://connect.raps.org/discussion/device-quarantine-notification#bmc686bb59-037f-4832-808c-0186c194b84a
• https://connect.raps.org/discussion/recall-in-the-us-for-medical-device#bm540b13f8-158f-4474-9500-0185ee83acd9

FDA's internal operating procedures associated with corresponding FDA regulations remind us that a manufacturer or distributor may voluntarily initiate a recall at any time. Initiation of a recall means a recalling firm's first communication about a voluntary recall, to its direct accounts or to the public. Accordingly, I reiterate the need for careful deliberation about how a firm categorizes its "dear customer" letters (see my preceding post linked above).  FDA's internal procedures say that FDA may conduct "informal" discussions with a firm that include voluntary recall as an option. FDA may also request a recall, as provided for under 21 CFR 7.45. Under certain authorities (see Part 810), FDA may mandate a recall.

FDA's internal procedures are that the agency may inform a firm that a product violates the law and may recommend that the firm cease distribution and recall the product without specifically requesting a recall. If a firm decides to recall under these circumstances, the firm's action is considered a firm-initiated recall under 21 CFR 7.46(c). If a firm asks whether FDA is requesting a recall, then FDA's procedure is that it should explain that the agency is not requesting a recall since a determination under 21 CFR 7.45 hasn't yet been made by FDA, and that the agency has not exercised its authority under 21 CFR 7.45, or invoked its mandatory recall authority. This recommendation does not preclude FDA from considering other actions in the future.

If the firm does not agree to cease distribution and/or recall following FDA's recommendation, then the agency may consider further action, as appropriate, including, but not limited to, public notification to consumers, healthcare practitioners, etc., an FDA-requested recall letter, an FDA-mandated recall (in the case of certain regulated products), seizure, administrative detention, or injunction.

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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: 17-Mar-2023 10:50
From: Dan O'Leary
Subject: Device Recalls – Mandatory vs Voluntary

There are some recent posts about recall authority and the distinction between mandatory and voluntary recalls. I recently read "Use of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration's 510(k) Pathway and Risk of Subsequent Recalls" by Kadakia et al in the Journal of the American Medical Association.

The article says, "Voluntary, manufacturer initiated recalls are the usual approach for medical device recalls, with the FDA exercising its recall power only 3 times between 1990 and 2010" citing the source as Institute of Medicine. Medical Devices and the Public's Health: the FDA 510(k) Clearance Process at 35 Years. The National Academies Press; 2011.<o:p></o:p>

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Dan O'Leary CQA, CQE
Swanzey NH
United States
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This is correct - many times FDA will "recommend" a recall be conducted, and even make it sound like a demand. I view one of the roles of regulatory is to understand the fact that it is not a requirement and the firm needs to make their own decision. That said, most of the time, the firm should likely follow the recommendation, for myriad reasons. That said, in 2 cases where I was personally involved, we chose not to recall and/or remove the devices, because we firmly believed we understood the risk factors FAR better than FDA did in those specific circumstances. This also included a request to "stop selling the devices" in one case.

Yes, FDA could have taken further actions, up to getting a court order to stop distributing, but the burden on them to use either their recall or injunction authorities are high, and they chose not to. We felt we had the evidence to convince a court we were in the right in these cases, so were willing to take that small chance. As it turns out, we were correct in both cases - devices were used correctly with no injuries and patients with no alternatives were helped. In once instance it actually kept the company in business as well. That said, we made the decision with "eyes wide open" as to potential longer term consequences that happily did not emerge. 

We were, however, completely within our rights per the regulations.

Ginger

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Ginger Glaser RAC
Chief Technology Officer
MN
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Original Message:
Sent: 20-Mar-2023 13:30
From: Kevin Randall
Subject: Device Recalls – Mandatory vs Voluntary

Here are links to some prior Forum discussions giving deeper insights on the matter of mandatory vs. voluntary recalls:

• https://connect.raps.org/discussion/med-device-recall-customer-responsibility#bm61338aa9-f35a-44cf-b00a-0186602da4c7
• https://connect.raps.org/discussion/device-quarantine-notification#bmc686bb59-037f-4832-808c-0186c194b84a
• https://connect.raps.org/discussion/recall-in-the-us-for-medical-device#bm540b13f8-158f-4474-9500-0185ee83acd9

FDA's internal operating procedures associated with corresponding FDA regulations remind us that a manufacturer or distributor may voluntarily initiate a recall at any time. Initiation of a recall means a recalling firm's first communication about a voluntary recall, to its direct accounts or to the public. Accordingly, I reiterate the need for careful deliberation about how a firm categorizes its "dear customer" letters (see my preceding post linked above).  FDA's internal procedures say that FDA may conduct "informal" discussions with a firm that include voluntary recall as an option. FDA may also request a recall, as provided for under 21 CFR 7.45. Under certain authorities (see Part 810), FDA may mandate a recall.

FDA's internal procedures are that the agency may inform a firm that a product violates the law and may recommend that the firm cease distribution and recall the product without specifically requesting a recall. If a firm decides to recall under these circumstances, the firm's action is considered a firm-initiated recall under 21 CFR 7.46(c). If a firm asks whether FDA is requesting a recall, then FDA's procedure is that it should explain that the agency is not requesting a recall since a determination under 21 CFR 7.45 hasn't yet been made by FDA, and that the agency has not exercised its authority under 21 CFR 7.45, or invoked its mandatory recall authority. This recommendation does not preclude FDA from considering other actions in the future.

If the firm does not agree to cease distribution and/or recall following FDA's recommendation, then the agency may consider further action, as appropriate, including, but not limited to, public notification to consumers, healthcare practitioners, etc., an FDA-requested recall letter, an FDA-mandated recall (in the case of certain regulated products), seizure, administrative detention, or injunction.

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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: 17-Mar-2023 10:50
From: Dan O'Leary
Subject: Device Recalls – Mandatory vs Voluntary

There are some recent posts about recall authority and the distinction between mandatory and voluntary recalls. I recently read "Use of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration's 510(k) Pathway and Risk of Subsequent Recalls" by Kadakia et al in the Journal of the American Medical Association.

The article says, "Voluntary, manufacturer initiated recalls are the usual approach for medical device recalls, with the FDA exercising its recall power only 3 times between 1990 and 2010" citing the source as Institute of Medicine. Medical Devices and the Public's Health: the FDA 510(k) Clearance Process at 35 Years. The National Academies Press; 2011.<o:p></o:p>

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Dan O'Leary CQA, CQE
Swanzey NH
United States
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