Regulatory Open Forum

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  • 1.  Why there is a k number when the device code is 510(k) exempt?

    Posted 12 days ago

    Hi RAPS community,

    As the title indicates, we have a device that belongs to a product code which is 510(k) exempt but we searched on FDA website and found that there is one predicate device that has a k number.

    My question is Why there is a k number when the device code is 510(k) exempt? do we need to file a 510k in such case.

    Thank you in advance.



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    Lulu (Silu) Zhang
    PRRC/Management Representative
    Head of Quality and Regulatory Affairs
    Canada
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  • 2.  RE: Why there is a k number when the device code is 510(k) exempt?

    Posted 12 days ago

    Generally speaking, this means that the subject device previously required a 510(k), but then FDA later (such as via the 21st Century Cures Act) down-graded the category into a 510(k)-exempt class. For example, scroll down the page at this link to see Cures Act exemptions. Ultimately, we need to know the particular classification regulation and product code for your subject device to definitively link it to a particular 510(k)-exemption announcement, which may or may not be part of the Cures Act list.



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    Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------



  • 3.  RE: Why there is a k number when the device code is 510(k) exempt?

    Posted 11 days ago

    Hello Silu,

    The other reason might be the device "exceeded limitations" of the regulation meaning they were making claims and/or indications for use statement that no longer made the device exempt status.  As Kevin says, we would need to know the Product Code, understand if there was a previous Federal Register notice, and the "age" of the 510(k) number because indeed it might have required a 510(k) at some point in time and is now 510(k) Exempt status.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Principal Strategy Consultant
    NAMSA
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  • 4.  RE: Why there is a k number when the device code is 510(k) exempt?

    Posted 11 days ago

    Thank you Kevin for replying.

    The product code is ITW and the product is foot orthotics.

    THank you.



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    Lulu (Silu) Zhang
    PRRC/Management Representative
    Head of Quality and Regulatory Affairs
    Canada
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  • 5.  RE: Why there is a k number when the device code is 510(k) exempt?

    Posted 11 days ago

    It appears that the ITW scenario is a case like Richard wisely and rightly mentioned. Specifically, a case where the subject device exceeded the 510(k)-exemption limitations in the ".9" segment of the classification regulations (in this case, 21 CFR section 890.9).  This appears to be the case because limb orthotics were originally classified as 510(k)-exempt (and GMP-exempt) back in 1983, and because there doesn't appear to have been any withdrawal of those exemptions since that time. In other words, for your case, the 510(k) you cited likely represents a foot orthotic for which the intended use and/or indications for use exceeded the 890.9 limitations, thus necessitating a 510(k).



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    Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------



  • 6.  RE: Why there is a k number when the device code is 510(k) exempt?

    Posted 11 days ago

    Hello Silu

    This could also happen even after FDA down-classified a device category to be 510(k) exempt, IF the manufacturer exceeded the exemption limits.  For example, added a wireless or other feature feature or expanded the intended use beyond what was allowed in the description (basic 'add-ons').  Then the company would be obligated to file a 510(k).



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    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
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  • 7.  RE: Why there is a k number when the device code is 510(k) exempt?

    Posted 11 days ago

    Thank you Ginger for your reply!



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    Lulu (Silu) Zhang
    PRRC/Management Representative
    Head of Quality and Regulatory Affairs
    Canada
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  • 8.  RE: Why there is a k number when the device code is 510(k) exempt?

    Posted 11 days ago

    We actually have A numbers for 2 of our device lines as in the 80s they were not exempt.  Now, one is Class I (Exempt) and the other is Class I.  The FDA has periodically lowered classifications on devices.  When that happens, the 510(k) does not disappear.  It remains searchable.  However, we are not required to report that number on any documents or registrations as it is no longer applicable based on the current FDA classification of our devices.

     

    For example, when applying for a CFG, the old 510(k) is not found, but can be searched other ways on the FDA website.

     

    I hope this helps.

     

    D. Michelle Williams, CESCO

    VP – Operations

     

    Action Products, Inc.

    www.actionproducts.com

    301.797.1414 X1022

     

    https://www.linkedin.com/in/dmwilliamsvpopapiwvu88

     

     

    Action-MMD-Ribbon_Logo_5in_cmyk

     






  • 9.  RE: Why there is a k number when the device code is 510(k) exempt?

    Posted 11 days ago
    Thank you so much, this is very helpful.

    --
    Kind regards, Lulu




  • 10.  RE: Why there is a k number when the device code is 510(k) exempt?

    Posted 11 days ago

    Here is the Federal Register notice from when the classification was made exempt. See page 33 of the PDF:

    https://archives.federalregister.gov/issue_slice/1983/11/23/53007-53062.pdf



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    Anne LeBlanc
    United States
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