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  • 1.  Correction ?

    Posted 26-Mar-2018 17:34

    Hi,

     

    If there are software bug fixes carried out for the software of your device and this is done by installing the new software from a website by the user / distributor / in rare  cases company service technicians , would that be called a correction ? Does it need to be assessed for reportability?

     

    Thanks & Regards,

     

    Rashmi Pillay
    Regulatory Affairs Associate


    Ellex 

    3-4 Second Avenue

    Mawson Lakes SA, 5095

     

    T + 61 8 7074 8105
    E  rpillay@ellex.com

    W ellex.com

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  • 2.  RE: Correction ?

    Posted 27-Mar-2018 08:12
    Hello Rashmi,

    Yes, it does need to be assessed for reportability if this was a bug not previously identified as a low level bug with essentially no risk.

    Example:  If you had identifed this as a low level no risk open anomaly at the end of the last software V&V cycle, and this was part of planned maintenance then I wouldn't worry about it because software is routinely updated to maintain it. 

    But if you had NOT identified this before, and it was complaint related (whether internally or externally discovered), then you have to evaluate it as a complaint including need for adverse event reportability, correction/recall consideration.  Please remember the internal complaint part. Maybe your software developers found a new bug while working on the code. This is an example. That could/should  be evaluated for impact on S&E.

    I had one like this where developers noticed something and unfortunately it was big enough to report as medical device adverse event (potential for a malfunction with safety impact), and it turned into a global recall of that version. Unfortunate but at least the developers notified me.

    Good luck-be sure to look at it carefully to determine if this is planned versus oops; perfective minor revisions, etc. Tie it to risk management as you decide.

    Best regards,

    Ginger Cantor, MBA, RAC
    Centaur Consulting LLC centaurconsultingllc@gmail.com
    (+1) 715-307-1850 



    Original Message


  • 3.  RE: Correction ?

    Posted 16-Apr-2018 16:55
    About Ginger's comment "Yes, it does need to be assessed for reportability if this was a bug not previously identified as a low level bug with essentially no risk."

    I think any complaint at point of use must be assessed for reportability and it is regardless of whether it was already identified as a risk or not. But routine servicing/maintenance is exempt for 806 reporting. So if such s/w fixes (downloading from website for example) are part of risk mitigation plan as routine fixes, then that can be used as rationale for not reporting. But it would still trigger a reportability decision making process, even if it is a previously identified low risk event at point of use. Whether that is adverse event reporting or 806 reporting, is dependent on number of such complaints.

    Please correct me if I'm wrong.



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    Vidyalakshmi Jayaraman
    Marlborough MA
    United States
    ------------------------------

    Original Message


  • 4.  RE: Correction ?

    Posted 17-Apr-2018 08:28
    Hello Vidyalakshmi,

    Good comment!

    What I meant about low level risk is something known at release (open anomaly) that has no safety/efficacy impact  would never be reportable. So other than identifying it as a complaint "yes we know that and it not reportable" there is generally no other issue.

    During initial look to see if an extensive investigation is needed,perhaps  this bug occurred in sequence you didn't anticipate, you might do even more investigation. But in the end, if it itself does not affect safety/efficacy it is not going to be reportable.

    These low levels can typically also be described or included in user facing software release notes.   Anything seriously impacting product safety or efficacy that is known as an open bug should cause the cancellation of a planned release until fixed.

    Best regards,

    Ginger Cantor, MBA, RAC
    Centaur Consulting LLC centaurconsultingllc@gmail.com



    Original Message


  • 5.  RE: Correction ?

    Posted 27-Mar-2018 08:18
    Yes these need to be assessed for applicability of 21CFR806. Software is really tricky, because generally there are "bug fixes" in every release (even if that wasn't main intent) and one could then argue upgrading is "correcting." Generally I'd advice to have a very good risk-based way of assessing these changes for reportability. It has been one thing that FDA has periodically gone after in 483s and warning letters.

    g-

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    Ginger Glaser RAC
    Chief Technology Officer
    MN
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    Original Message


  • 6.  RE: Correction ?

    Posted 13-Apr-2018 00:23
    ​Hi ,

    Reverting to this query on software bug fixes. Once you determine its not a recall , you still need to have the record for 21CFR 806.20 ? Is that right?

    Regards,

    Rashmi

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    RashmiAdelaideAustralia
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    Original Message


  • 7.  RE: Correction ?

    Posted 16-Apr-2018 16:27
    Yes. With rationale for why it was not a reportable event.

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    Vidyalakshmi Jayaraman
    Marlborough MA
    United States
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    Original Message


  • 8.  RE: Correction ?

    Posted 17-Apr-2018 00:40
    ​And for optional field upgrades /corrections which are manageable through advisory notices and followed by correction ( during routine service - non mandatory , non safety related) , are these to be recorded under 21 CFR 806.20, also?

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    RashmiAdelaideAustralia
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    Original Message


  • 9.  RE: Correction ?

    Posted 17-Apr-2018 09:59
    You may be mixing things up. A correction is NOT the same as an optional field upgrade. A correction is needed when there is a malfunction affecting safety and/or performance of the device and continued use of it will increase risk to health. If you have determined that the bug could be fixed through routine maintenance (MUST be documented as such in risk management), then a 806 report as per 21 CFR 806.10 is not required, but you will need to record it as per 806.20 with rationale for not reporting. If the bug fix involves a repair technician/ removal of machine/ any other fix that is part of your risk mitigation i.e. not an anticipated error, it would most likely be a reportable event.

    An optional field upgrade because its 'optional', is essentially to improve existing performance. As per 21 CFR 806.1 below, you need not report. Any upgrade to improve safety or remedy a safety violation is NOT optional.

    b) The following actions are exempt from the reporting requirements of this part:

    (1) Actions taken by device manufacturers or importers to improve the performance or quality of a device but that do not reduce a risk to health posed by the device or remedy a violation of the act caused by the device.

    (2) Market withdrawals as defined in 806.2(h).

    (3) Routine servicing as defined in 806.2(k).

    (4) Stock recoveries as defined in 806.2(l).

    Hope this helps.



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    Vidyalakshmi Jayaraman
    Marlborough MA
    United States
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    Original Message


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