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  • 1.  FDA device listing number with a prefix E instead D

    Posted 21-Feb-2024 14:11

    Hi,

    I am helping a medical device importing company to process their FDA registration. The foreign manufacturer provided them a device listing number for the product that they will import to the U.S.. However, the device listing number has a E prefix instead of a D prefix, which I am more familiar with. What is the difference between E and D prefix? Will it be an issue during the custom clearance for the product?

    Thank you for your input.

    Vivian 



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    Yunyuan Wang
    Consultant
    Self-Employed
    Tustin CA
    United States
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  • 2.  RE: FDA device listing number with a prefix E instead D

    Posted 22-Feb-2024 04:42
    Edited by Richard Vincins 22-Feb-2024 04:43

    Hello Yunyuan,

    First, no this will not have any impact on bringing product through customs clearance.  This goes back years and years, where FDA used to have "E-" prefixes back when manual medical device listing was done - I do not even remember the Form number it was that long ago now.  Some previous registrations prior to electronic registration products had an "E-" prefix, but there is no difference between the D or E.  Nowadays, the medical device listing number is generated by the electronic system.  I guess when they run out of numbers, might be another prefix letter would be used.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Principal Strategy Consultant
    NAMSA
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    Original Message


  • 3.  RE: FDA device listing number with a prefix E instead D

    Posted 22-Feb-2024 08:41
    Hello Vivian,

    I do not know the difference and/or decision making into the letter prefix, but I have devices with both E and D prefixes and there is not Customs issue with them.

    Best regards,
    James




    Original Message


  • 4.  RE: FDA device listing number with a prefix E instead D

    Posted 22-Feb-2024 11:41

    I suspect it doesn't matter and it is just the next in the series of listing numbers they issue. Many years ago, early in my career, we had a bunch of listings with "A" and "B" numbers and it all worked the same.

    Ginger



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    Ginger Glaser RAC
    Chief Technology Officer
    MN
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    Original Message


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