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  • 1.  Abbreviated 510(k)

    Posted 22-May-2014 00:30
    Colleagues,

    Since abbreviated 510(k) is cleared based on guidance documents, special controls and recognized standards. I am wondering if a predicate device would be needed to establish substantial equivalence for abbreviated 510(k) application.

    Thank you!

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    Ranyang Li
    Process Development Engineer
    Tissuegene, Inc
    Rockville MD
    United States
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  • 2.  RE: Abbreviated 510(k)

    Posted 23-May-2014 07:17
    Ranyang,

    The Abbreviated 510(k) is a type of premarket notification and as such has to meet the requirement of substantial equivalence including a

    • comparison with a predicate device(s), indicating similarities and/or differences accompanied by data, as appropriate; this information may include an identification of materials, design considerations, energy expected to be used or delivered by the device, and a description of the operational principles of the device.

    The Abbreviated submission allow the submitter to reduce the amount of documentation provided in the notification to summary reports and a Declaration of Conformity.

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    Robert Bard JD RAC
    Vice President, Regulatory/Clinical/Quality Systems
    Healthcare Technologies Consultants
    South Lyon MI
    United States
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    Original Message


  • 3.  RE: Abbreviated 510(k)

    Posted 23-May-2014 07:24
    Dear Colleague

    The answer is yes.

    Please see "Content / Format of an Abbreviated 510(k)" here
    http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134574.htm

    You will find this in the text:
    "comparison with a predicate device(s)25, indicating similarities and/or differences accompanied by data, as appropriate; this information may include an identification of materials, design considerations, energy expected to be used or delivered by the device, and a description of the operational principles of the device."

    In some cases one might think that some of the devices which are suitable for an Abbreviated 510(k) are comparable to an OTC Monograph for drugs, where safety and performance characteristics have been specified conprehensively (although in a Recognized Consenus Standard as opposed to the Federal Register).

    However not all of these devices are like that. Some are suitable for Abbreviated 510(k) but still have a variation in technological or performance characteristics.

    And the basis of the 510(k) is after all substantial equivalence to a legally marketed device, namely the predicate device.

    Good luck!

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    Jean Bigoney PHD
    Managing Member
    Nu Device Consulting LLC
    Newport NH
    United States
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  • 4.  RE: Abbreviated 510(k)

    Posted 25-May-2014 01:53
    Ranyang,

    An abbreviated 510(k) still must include the required elements of  510(k); the advantage of an abbreviated 510(k) is that you can rely on the use of guidance documents, special controls and standards to expedite submission review with summaries and under certain conditions, data may not need to be submitted. You still need to demonstrate that the device is substantially equivalent in intended used as a predicate device.  Section (f) 21 CFR 870.87, see guidance document on Preparing an Abbreviated device: (f) A statement indicating the device is similar to and/or different from other products of comparable type in commercial distribution, accompanied by data to support the statement. This information may include an identification of similar products, materials, design considerations, energy expected to be used or delivered by the device, and a description of the operational principles of the device.

    Hope this is helpful,

    Dar

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    Darlene Rosario
    Principal Consultant RA, Quality and Compliance
    Velocity Consulting
    Ventura CA
    United States
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    Original Message