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  • 1.  MDR Malfunction Reporting Requirements 21 CFR 803 (Internal Event)

    This message was posted by a user wishing to remain anonymous
    Posted 19-Feb-2019 20:40
    This message was posted by a user wishing to remain anonymous

    My question is about the intent and scope of 21 CFR 803. Specifically, if the 803 malfunction reporting requirement applies to devices that aren't in the field and are being serviced/reprocessed/manufactured at the manufacturing facility. For example, if a manufacturer observes a malfunction during the manufacturing/servicing/reprocessing process i.e., the device is in house and not in the field, is medical device reporting required? If the malfunction were to occur externally it would be likely to cause or contribute to death or serious injury. The rationale for not reporting is that since the device is not a finished good and not released, the chances of the observed in process malfunction causing death or serious injury are remote and MDR reporting is not required. Additionally, malfunctions that are observed during the manufacturing/reprocessing process might not be indicative of malfunctions that would occur with finished devices. It seems that the intent of 21 CFR 803 is to report adverse events and malfunctions that occur externally, with released devices. If the malfunction is isolated, would tracking and trending be an appropriate approach? I am interested if anyone else has ever submitted an MDR for a malfunction that was observed internally after servicing or reprocessing. I would appreciate feedback from any seasoned professionals that have worked with Class III devices.

    Thank you.



  • 2.  RE: MDR Malfunction Reporting Requirements 21 CFR 803 (Internal Event)

    Posted 20-Feb-2019 08:00
    ​I think you answered your own question. If the malfunction observed is an artifact of the manufacturing, reprocessing, servicing activities (i.e. malfunction is due to process such as the case melts when subjected to welding), and could not occur in the field, then you do not need to submit.  However, regardless as to where the malfunction is observed, if it is a type of malfunction or a specific failure that could occur in the field (and is likely to cause injury if it were to reoccur), then it s reportable.


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    Lee Leichter RAC
    President
    Fort Myers FL
    United States
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  • 3.  RE: MDR Malfunction Reporting Requirements 21 CFR 803 (Internal Event)

    This message was posted by a user wishing to remain anonymous
    Posted 21-Feb-2019 08:34
    This message was posted by a user wishing to remain anonymous

    ​So if the malfunction is observed in the final test for release, which identifies the malfunction (serving the purpose of release testing) and prevents release to the field, in this scenario MDR for the malfunction is still required? It seems odd that reporting is required if the malfunction is identified prior to release. This seems like it would fall under manufacturing controls and would be considered an NCR rather than an MDR. Anyone have a different interpretation?


  • 4.  RE: MDR Malfunction Reporting Requirements 21 CFR 803 (Internal Event)

    Posted 21-Feb-2019 20:05

    To understand whether MDR reporting is required for an "internal event" discovered during the "manufacturing/servicing/reprocessing" process, it is necessary to carefully consider some fundamental principles anchoring FDA's requirements for complaint handling, MDR reporting, device servicing, and device acceptance requirements.

     

    First, remember that the general complaint screening requirements [21 CFR 820.198(a) first paragraph] are what give rise to the MDR evaluation and reporting requirements of 820.198(a)(3) and, in turn, 21 CFR part 803.  Accordingly, all MDR reportable events are complaints, while all complaints are not MDR reportable events.  In other words, if an issue doesn't meet the definition of "complaint", then it doesn't meet the definition of MDR reportable event.  Therefore, as one examines the MDR reportability of an "internal event" discovered during the "manufacturing/servicing/reprocessing" process, it is first prerequisite to screen the issue against FDA's definition of "complaint".

     

    On that note, it is important to remember that during the proposed rule phase of FDA's Quality System Regulation, FDA initially proposed an overly broad definition for "complaint".  Specifically, "…Any written, electronic, or oral communication that relates to or concerns the unacceptability of the identity, quality, durability, reliability, safety, effectiveness, or performance of a device…", period.  Well, by that definition, any "internal event" discovered during the "manufacturing/servicing/reprocessing" process could trigger the complaint threshold (and thus possible MDR reporting).  Not surprisingly, objections about that very notion were in fact submitted to FDA regarding the proposed "complaint" definition.  Specifically, objections stated that the definition was unclear and could be interpreted to include routine service requests and "internal communications".  Luckily for us, FDA thereafter clarified that (with one exception on which I elaborate in my next paragraph) it didn't intend for "in-house indications of dissatisfaction" to be within the intended scope of 820.198 (nor by default, Part 803).  FDA stated that information generated in-house relating to quality problems should instead be documented and processed under 820.100.  [This would presumably be via, for example, 820.90 (nonconforming product), 820.22 (quality audit), 820.20(c) (management review), etc].  To ultimately settle these objections, FDA modified the "complaint" definition to clarify that complaints (and thus MDR reporting) only apply to a device after it is released for distribution.  This is because the fundamental intent of complaint handling and MDR reporting is to help better understand and control a device's risk profile and usage characteristics organically in light of the dynamic factors and forces involved with the real-life distribution and use of the product.  Therefore, we can safely conclude that nonconforming product discovered during receiving, in-process, and finished device acceptance or associated rework/reprocessing prior to release for distribution are not generally subject to complaint handling nor MDR reporting.  Instead, such nonconformities are to be handled via 820.80 in conjunction with 820.90 and as needed, 820.100.

     

    However, due to the intrinsic scope of "complaint" (and thus "MDR reportable event") being limited to devices after release for distribution, there is an important caveat that applies if the nonconforming product is discovered in association with the device servicing process.  This seems to be because a device getting serviced is presumed to have been previously distributed and/or used.  The caveat is that, as part of the aforementioned preamble resolution of the "complaint" definition, FDA made it clear that service requests/reports are not viewed by FDA, for the purposes of complaint/MDR screening, to be "internal / in-house communications" even when such feedback could be, and often is, lodged internally, such as by the firm's service department [which happens most often when, during "routine servicing" (21 CFR 806.2), a service technician discovers other nonconformities exceeding the threshold of "routine servicing"].  Indeed, there is a large body of supporting precedent showing us that FDA requires all service requests/reports (including ones originating from internal analyses/evaluation) to be screened for complaints (and thus MDR reportable events).  For example, FDA stated in its old Medical Device Quality Systems Manual (written for the Quality System Regulation) that even if the feedback comes from internal sources like service representatives and internal analyses, the feedback could be a "complaint" (and thus be subject to MDR reportability evaluation).  In fact, FDA investigators are trained (see the QSIT guide and FDA Investigations Operations Manual) to look for complaints in service data.  These precedents are principally driven by 820.200(c) (stating that MDR-reportable service requests must be processed as complaints) for which, despite its misleading language, FDA has officially stated is not limited to just MDR-reportable events.  Instead, 820.200(c) requires that any service request/report containing a complaint must be processed according to 820.198 (and in turn, 803 as needed).  For additional examples of such precedents, feel free to raise further corresponding inquiries.

     

    Finally, when it comes time to assess the MDR reportability of malfunctions noted during the servicing process (or other post-release contexts), be mindful of the potentially-broad scope of the basic MDR reporting threshold for malfunctions: Specifically, if the device has malfunctioned and the device or a similar device that you market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur, then an MDR report is required.

     

    Hope this helps,



    ------------------------------
    Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden CO
    United States
    www.complianceacuity.com
    © Copyright 2019 by ComplianceAcuity, Inc. All rights reserved.
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  • 5.  RE: MDR Malfunction Reporting Requirements 21 CFR 803 (Internal Event)

    Posted 22-Feb-2019 07:34
    ​You are not very specific in the situation you describe, but seem to be asking if it OK not to file.  It is hard to be definitive in response.

    However, I think the criteria is if this malfunction CAN occur in marketed products (i.e. it is not completely prevented by your design mitigations or 100% detected and prevented before release), then it is reportable.  The intent is that even if you "become aware" of the potential for this to occur in a legally marketed product that has left your control, during or due to your internal research, testing inspection, servicing etc., you are required to report.  The key consideration is whether there is the potential for this to occur "in the wild".

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    Lee Leichter RAC
    President
    Fort Myers FL
    United States
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  • 6.  RE: MDR Malfunction Reporting Requirements 21 CFR 803 (Internal Event)

    Posted 22-Feb-2019 21:02
    ​I think Lee has provided a great explanation of a critical bottom line, namely, "...if this malfunction CAN occur in marketed products (i.e. it is not completely prevented by your design mitigations or 100% detected and prevented before release), then it is reportable..."

    While at first glance it may seem to translate to more MDR reports, in actuality, it is an important parameter needed to keep in check one particular aspect of FDA's MDR reporting stance; specifically, FDA's longstanding position (e.g., see item 2.14 of FDA's latest MDR guidance document) that if a malfunction occurred once, then FDA automatically presumes it will recur.  Without such a qualifier, MDR reports would be unnecessarily submitted for a large constellation of nonconformities / malfunctions routinely discovered during pre-release acceptance testing.  Indeed, without such a delimiter, it could easily mean for many devices, especially class III devices, that virtually every nonconformity detected during manufacturing would require an MDR report. This reiterates the criticality of carefully considering a malfunction's nature and orientation with respect to FDA's "after release for distribution" clarifier described in my preceding post.

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    Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden CO
    United States
    www.complianceacuity.com
    © Copyright 2019 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------



  • 7.  RE: MDR Malfunction Reporting Requirements 21 CFR 803 (Internal Event)

    Posted 23-Feb-2019 10:24

    The initial question asked about devices serviced/reprocessed/manufactured at the manufacturing facility. I think you need to divide them into separate cases. I don't think the location of the activity, (at the manufacturing facility) is significant. However, servicing may occur at the location of the device.

    A device being serviced has been released for distribution, 820.80(d), and falls under 820.200. Under 820.200(c), if the service record suggests a reportable event under 803, then it must also be a complaint under 820.198. Under 820.198, evaluate the information for potential reportability, open an MDR Event File, and report if warranted. This also applies to the malfunction leg of reportability. A serviced device will go back into use unchanged in performance indications.

    For reprocessed device, there is some ambiguity. The device could be reprocessed in the sense of cleaning and sterilization. In this case it goes back into use unchanged in performance indications, similar to the servicing case.

    A reprocessed device could be a single use device reprocessed for another use. The reprocessor in this case is a manufacturer and the device is not yet released for distribution.

    In the manufacturing case the device is not released for distribution, so neither complaints nor servicing apply.

    IF in doubt, file an MDR. I've never seen a Warning Letter for filing too many MDRs, but there are many for not filing enough.



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    Dan O'Leary
    Swanzey NH
    United States
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  • 8.  RE: MDR Malfunction Reporting Requirements 21 CFR 803 (Internal Event)

    This message was posted by a user wishing to remain anonymous
    Posted 01-Mar-2019 09:42
    This message was posted by a user wishing to remain anonymous

    Thank you for the thorough explanations! I agree that over reporting is always better than under-reporting. I was trying to understand NCR/MDR line of separation.