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  • 1.  Change to Parent device and accessory

    Posted 02-Feb-2019 20:12
    Hi,
     
    Please advise what I need to do here . This is regarding sterile devices.
     
    Parent device – cleared by 510(k). Accessory to the parent device cleared through its own 510(k). Earlier accessory was a separate device which had to be attached to the parent device and now the accessory is pre-attached to the parent device.
     
    Question :
    Does the combined device now become the parent device and do I need to assess the change from the cleared parent device ? or
    Do I need to assess the change individually for the parent device and accessory?
     
     
    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
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  • 2.  RE: Change to Parent device and accessory

    Posted 04-Feb-2019 21:56
    Rashimi, I can't help you with your question, but I can give you a tip about posting to the Forum.  The timing of your post was such that it was included in the email that summarized everything that was posted to the Forum on Saturday.  This email comes out on ​Sunday morning in the US, which means hardly anyone ever reads it.  This probably explains why you haven't gotten any replies, because I think there must be any number of people here who could help you.

    As I said, I can't help you with your question, but since it is Monday night here, my reply should be included in the email that comes out tomorrow, on Tuesday.  Hopefully it will get some attention!

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 3.  RE: Change to Parent device and accessory

    Posted 05-Feb-2019 22:36
    Ok, still crickets, so I'll give it a shot.

    If the pre-attached accessory will not also be sold separately, I'd treat the combination device as a change to the parent device and assess the change to the parent device.​  I would also stop calling it an accessory and start calling it a component, per 21CFR 820.3(c).

    If the pre-attached accessory will also be sold separately, I'd assess the change individually for parent and accessory.

    I have no regulatory justification for this, just seems right to me.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 4.  RE: Change to Parent device and accessory

    Posted 06-Feb-2019 08:49
    Hi folks.

    I think some might be getting caught up in the idea that the "now accessory" is also cleared under its own 510(k).  I tend to agree with Julie's rationale in that if the "accessory" is no longer to be distributed individually on its own, then the review and update would be to the parent product 510(k) and that is where I would likely stop (except possibly to discuss with FDA whether or not I could eliminate the accessory 510(k) from my registration and thereby save some user fee money).

    If, however, the company plans to continue to offer the accessory individually then you need to review each item independently and I would likely review the issues with the accessory first because the information documented there will be useful for reviewing the overall parent device accurately.  Think about it, if you review the parent device first and then start to review the accessory and find something changed you would need to go back and determine if that information also causes or prompts a change in the parent device.

    So I do truly think it comes down to understanding what exactly is planned by the company with respect to the plans for commercialization.  If you commercialize the parent device with the accessory as the only option then you would review under one set of circumstances.  If you instead choose to continue marketing both the parent device with and without the accessory or if you plan to continue marketing the accessory independently of the parent device you would need to look at this a bit differently.​

    ------------------------------
    Victor Mencarelli
    Director Regulatory Affairs
    United States
    ------------------------------

    Original Message


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