Regulatory Open Forum

 View Only
  • 1.  Complaints again - 'Possible failure'

    Posted 09-Feb-2019 23:37
    As per 21 CFR 820.198 "(c) Any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications shall be reviewed, evaluated, and investigated, unless such investigation has already been performed for a similar complaint and another investigation is not necessary."
    How do you determine it's a 'possible failure' , do you need to check the complaint against the device PRS/SRS ? For example 50% of our complaints involve device error states whereby it reverts to standby and the modules needing to be replaced. There's a debate whether this is considered as failure of the device or a device feature . Or do you need to consider the device reliability to determine the failure ?
    Thanks & Regards,
    Rashmi Pillay
    Regulatory Affairs Associate

    3-4 Second Avenue
    Mawson Lakes SA, 5095
    T + 61 8 7074 8105
    One Powerful Vision.
    Confidentiality: This e-mail is from Ellex Medical Pty Ltd, ABN 35 008 276 060. The contents are confidential and intended only for the named recipient of this e-mail. If the reader of this e-mail is not the intended recipient you are hereby notified that any use, reproduction, disclosure or distribution of the information contained in the e-mail is prohibited. Viruses: Any loss/damage incurred by using this material is not the sender's responsibility. No warranty is made that this material is free from computer virus or other defect. Ellex Medical Pty Ltd entire liability will be limited to resupplying the material. If you have received this e-mail in error, please reply to us immediately and delete the document. 


  • 2.  RE: Complaints again - 'Possible failure'

    Posted 11-Feb-2019 09:26
    Any complaint that implicates a device potentially not meeting its expected specifications or attributes in my opinion needs to be investigated to determine if the device, in fact, did not meets its specifications.  Only way to do that is to determine whether or not the device might be out of specification.  In other words, could the complaint indicate that something in the device did not function properly as expected.  If it is possible then a more detailed deep-dive review needs to happen.  Just because something is "warned of" in the documentation doesn't, in my opinion, completely exonerate the company from determining whether or not the device truly failed in some respect because if the device failed and if you are seeing a trend in failures of the device there is the potential that while the defect is warned of in the labeling or IFU the defect, if happening at a high rate, could easily change the benefit-risk ratio calculus.

    In your example, if the device were to have the issues you note, would that delay therapy or could that be something that would prompt additional medical attention or would the physician or patient be unable to perform a potentially necessary review of the data needed for proper treatment?  In any of these situations I would consider this a device failure that would need to be reviewed.  Has this issue been at 50% even when you were testing the device?  If it was only 20% of the time during testing and now 50% of your issues appear to be for this reason - something else very well could be impacting the device that needs to be understood and potentially rectified.  I truly don't think I look at "device failure" or "device feature failure" any differently.  If the device is meant to have a particular attribute and the device fails to perform according to that attribute, the device failed...feature or not, nice to have or essential, really shouldn't make any difference in the calculation of next steps in my opinion.  It might make a difference in the severity of the issue, but it is still an issue.

    Victor Mencarelli
    Director Regulatory Affairs
    United States