Regulatory Open Forum

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  • 1.  UDI Exception

    Posted 15-Feb-2016 11:31

    Hi! Has anyone successfully filed an UDI exception?  Any suggestions/tips on filing an exception for UDI? 

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    Jayshree Patel MS
    Regulatory Affairs Specialist
    Waters Corporation
    Milford MA
    United States
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  • 2.  RE: UDI Exception

    Posted 16-Feb-2016 12:22

    Hi,

    On a related note, CFR 801.45(e) says the following:

    Exception to be noted in design history file. A labeler that decides to make use of an exception under paragraph (d of this section) must document the basis of that decision in the design history file required by 820.30(j) of this chapter.

    The draft guidance on UDI (issued June 26, 2015) says the following in section III.D.4 (page 12):

    Please note that there is no reason to submit a 21 CFR 801.55 request for exception from UDI direct marking requirements if any exception under 21 CFR 801.45(d) is applicable

    So if an 801.45(d) exemption applies to your device, then you can handle it through internal documentation.

    However, the following document does not seem to take into account Section (d) exceptions.

    UDI Exceptions, Alternatives and Time Extensions

    Curious what others think about whether Exceptions that fall under 801.45(d) must be submitted for approval or shall they be documented internally? Basically, the Regulation and the draft Guidance seem to be at odds with the latter document.

    thanks

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    Vineet Sarin PhD
    President
    Kinamed Inc
    Camarillo CA
    United States

    Original Message


  • 3.  RE: UDI Exception

    Posted 16-Feb-2016 15:18
    Vineet,

    "Curious what others think about whether Exceptions that fall under 801.45(d) must be submitted for approval or shall they be documented internally?"

    Per/under 21 CFR 801.45(d), exceptions are generally obvious.  When it is obvious, firms should document in the DHF because we (industry) should refrain from asking obvious questions to the FDA. 

    However, sometimes, it is not so obvious.  when that happens, a firm should request for an exception or alternative by addressing "What/How/Why" that the FDA should grant an exception or alternative.  

    We should be aware that the FDA may/can revoke granting an exception later even if it is granted when it is not in the best interest of the public health. 

    Thank you.  

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



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    Original Message