Regulatory Open Forum

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  • 1.  Change/ Correction Assessment

    Posted 14-Feb-2018 05:43

    Hi ,

    Do all changes for existing devices need to be evaluated whether its a correction or not ? Do all corrections need to be evaluated for reportability to agencies?



  • 2.  RE: Change/ Correction Assessment

    Posted 14-Feb-2018 13:25
    Edited by Vidya Jayaraman 14-Feb-2018 14:22
    Hi Rashmi,

    I would say YES to both for FDA, depending upon what the change constitutes. I would like to hear what others have to say for EU and other countries. Its logical that you would need to report a design change whether or not its based on risk to health (following MEDDEV 2.12 for EU)

    Could you be specific about what kind of change you're referring to? Any change that would ultimately affect manufacturing, design, operation, clinical effect, end use or risk profile must undergo regulatory assessment and be reported to FDA. The assessment could reveal that you need one or more of:  further testing to ensure appropriate compliance, further risk analysis, changes to other design components, customer notification etc

    A 'correction' as per 21 CFR 806 is reparation done to a device that has been placed on the market at the point of use, which has either malfunctioned or posed a risk to health. This includes 'relabeling' and 'device destruction'. Such an event necessitates reporting to FDA within 10 working days. There are however exceptions that don't need reporting. So you can see, not all changes like supplier change, change of material or change of IFUs are a 'correction'.

    To your second question, once you've determined it IS a correction, you must report.

    ETA: Distinguishing Medical Device Recalls from Medical Device Enhancements is an FDA guidance that you may find helpful

    Vidyalakshmi Jayaraman
    Marlborough MA
    United States

  • 3.  RE: Change/ Correction Assessment

    Posted 15-Feb-2018 07:52

    For 510(k)s products, not all changes are reported to FDA, only those that could ssignificantly affect safety and efficacy. Most are usually evaluated internally and handled and maintained through the QMS. For PMA products, yes, ultimately all changes are reported one way or another (new PMA, Supplement, OR Annual Report).

    Each change is not necessarily a correction, it could be a design improvement without correction (new features, indications, etc).

    Best regards, 
    Ginger Cantor, MBA, RAC
    Centaur Consulting LLC
    (+1) 715-307-1850

  • 4.  RE: Change/ Correction Assessment

    Posted 15-Feb-2018 16:52



    According to 21 CFR 806 Correction means repair, modification, adjustment, relabeling, destruction, or

    inspection (including patient monitoring) of a product without its physical removal to

    some other location. (if the correction falls within the 21 CFR 806.1 exemption criteria , there is no reporting required)


    The definition also mentions 'modification' , so then do all changes to existing device fall within the scope of correction? How do you distinguish? Some corrections may not be critical ( may be cosmetic or a correction for a non –critical part) but nevertheless it's a correction if it falls within the definition, so should all corrections be assessed for reportability?


    During  the change process , when a change is  assessed for regulatory impact , should the assessment include :


    1)      Whether a change is a correction or not ? Criteria ?

    2)      If it's not a correction , then whether its significant or not for notification ?

    3)      If it's a correction or removal , then whether its reportable or not ?


    Sorry I am asking too many questions , but I am confused..



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    Regulatory Affairs Associate


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  • 5.  RE: Change/ Correction Assessment

    Posted 16-Feb-2018 10:06
    Edited by Vidya Jayaraman 16-Feb-2018 10:11

    During  the change process , when a change is  assessed for regulatory impact , should the assessment include :


    1)      Whether a change is a correction or not ? Criteria ?
    Removing/correcting products on field is an impactful activity which will be recorded in FDA recall database (I find the terminology hazy; I've seen any US field action being called 'recall' whether its strictly a correction or removal). So a decision to 'correct' should typically follow a thorough Health Hazard Evaluation which should be accompanied by a CAPA investigation. CAPAs are based on trends seen in complaints (malfunction and serious events). For example, if there have been 'x' number of complaints on a product which represents an adverse trend (this should be defined in risk mgmt based on severity of failure & probability of occurrence), then you would open a CAPA to investigate, which may be followed by an HHE. If its decided that a design change is required to mitigate the above malfunction that resulted in 'x' complaints, you should record that as a correction/removal if it applies to products already on market and report to FDA. If products on market will be repaired at point of use, its a correction. If they are removed from point of use to be destroyed, scrapped or repaired later, its a removal. I'm of the opinion that mostly companies 'remove' products and send customer notifications and product replacement (if its critical) to be on the safer side and because this happens typically on a batch of the same product, it is termed 'recall'.

    2)      If it's not a correction , then whether its significant or not for notification ?
    If you've determined its not a correction i.e. a nonconformity on product/product batch that's still in manufacturer control in manufacturing facility/warehouse OR a cosmetic correction OR a design change based on customer feedback/clinical literature i.e. the products already on market will NOT be affected by this change, there still needs to be regulatory assessment to determine impact on compliance to standards for safety and performance. For example, a supplier could change the percentage of dye in their plastic tubing. This may impact biocompatibility and tubing flexural, tensile properties. If its determined there needs to be additional testing (involve quality assurance, sterility departments), the additional tests must be performed and results recorded. The results could determine if there are changes to labeling like 'do not apply excessive manual force to remove catheter etc'. For a PMA product, this usually ends up in a notification (I don't know the process). 

    3)      If it's a correction or removal , then whether its reportable or not ?
    If its a correction / removal, you MUST ALWAYS report.

    Vidyalakshmi Jayaraman
    Marlborough MA
    United States