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  • 1.  Withdrawn 510(k) Guidance?

    Posted 12-May-2016 12:38

    Does anyone have a copy of the guidance on deciding when to submit a 510(k) for a change to an existing device that FDA withdrew in 2011?

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


  • 2.  RE: Withdrawn 510(k) Guidance?

    Posted 12-May-2016 14:33
    Julie,

    I suppose you may be referring to the Draft Guidance issued on 2011, but withdrawn on 2012-07-17

    Here we go here > 

    Thank you.  

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

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  • 3.  RE: Withdrawn 510(k) Guidance?

    Posted 13-May-2016 10:01

    David, thanks.

    Yes, issued 2011 and withdrawn 2012.  That fits better with my memory of the events, but, I'm getting old.  The list of withdrawn guidances seemed to indicate it was withdrawn in 2011, but re-reading that web page this morning, I'm no longer sure what it indicates:

    This page lists CDRH guidance documents that have been withdrawn. These documents only contain the withdrawal date. The original content is no longer available.

    http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm425025.htm

    ------------------------------
    Julie Omohundro, ex-RAC (US, EU), 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  RE: Withdrawn 510(k) Guidance?

    Posted 13-May-2016 11:04
    Julie:
    ?????? Did David answer your question? (I believe not).
    ???? If not we MAY still have a copy in our office. I suspect that the underlying question is the not having to test if all materials are used in approved products with the same therapeutic claim?? one - true in the old guidance, not now.
    ?????? From FDA - "we do not qualify/approve materials - we qualify products"

    Let me know if you want us to do some paper archeology.

    Shayne



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  • 5.  RE: Withdrawn 510(k) Guidance?

    Posted 13-May-2016 11:36

    Shayne, got it covered now, thanks.

    However, if you want to head over to the discussion of 510(k)s and biocompatibility, I'd still be very interested to hear your thoughts on that one.

    ------------------------------
    Julie Omohundro, ex-RAC (US, EU), 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


  • 6.  RE: Withdrawn 510(k) Guidance?

    Posted 13-May-2016 11:34

    Thanks to everyone who responded to my request.

    For those of you who, like me, didn't realize that FDA removes copies of withdrawn guidances from its website...it does, so if you want to have a copy of one for future reference, better grab it before the withdrawal date!

    ------------------------------
    Julie Omohundro, ex-RAC (US, EU), 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


  • 7.  RE: Withdrawn 510(k) Guidance?

    Posted 13-May-2016 11:58
    Julie,

    When I present to industry and professionals, I get challenged with various questions.

    Before I present, I have to be ready, willing and able to provide any evidentiary info to substantiate my statements. 

    Our referenced withdrawn guidance is used as an example for many of my statements. 

    I was glad you were seeking this withdrawn guidance as many others may think it is of no use. 

    D



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