Regulatory Open Forum

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  • 1.  Abbreviated or traditional 510(k)

    Posted 07-Oct-2017 08:31
    Would I submit a traditional or abbreviated 510(k) for a Class II device that is using the FDA recognized consensus standard for the device and declarations of conformity for other required bench tests, which will be performed using ISO and ASTM standards?

    Best regards,

    Ana Edwards
    Regulatory Affairs Specialist
    Burpee MedSystems, LLC
    Eatontown, NJ


  • 2.  RE: Abbreviated or traditional 510(k)

    Posted 07-Oct-2017 12:46
    I would say that it depends on the product, whether FDA fully recognizes (all sections), and/or if there are other FDA expectations for the product. But overall FDA's website states:

    Device manufacturers may choose to submit an Abbreviated 510(k) when:

    1. a guidance documents exists,
    2. a special control has been established, or
    3. FDA has recognized a relevant consensus standard.

    In an Abbreviated 510(k) submission, manufacturers elect to provide summary reports on the use of guidance documents and/or special controls, or declarations of conformity to recognized standards, to expedite the review of a submission.

    How to Prepare an Abbreviated 510(k)
    Fda remove preview
    How to Prepare an Abbreviated 510(k)
    There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the " New 510(k) Paradigm" to help streamline the 510(k) review process. The Abbreviated 510(k) relies on the use of guidance documents, special controls, and recognized standards.
    View this on Fda >

    It is usually easier to make that determination when there are special controls specific to the product then you can know exactly what to expect.

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    Viky Verna, MS BME, MS Pharm, RAC (Global)
    Senior Consultant
    Confinis AG
    Washington DC/United States
    Bern/Switzerland
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