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  • 1.  Abbreviated statement/brief summary

    This message was posted by a user wishing to remain anonymous
    Posted 19-Oct-2017 14:42
    This message was posted by a user wishing to remain anonymous

    I've been involved in some discussions regarding whether abbreviated statements/brief summaries are required for 510(k) products (for external marketing pieces in the US) or if they are only required for PMA products. I'd appreciate feedback on the topic from this expert medical device community as well.

    One of the main arguments against needing the risk statements for 510(k) products is that they are not "restricted", as per the act (in part): "(r) In the case of any restricted device distributed or offered for sale in any State, unless the manufacturer, packer, or distributor thereof includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to that

    device (1) a true statement of the device's established name as defined in section 502(e), printed prominently and in type at least half as large as that used for any trade or brand name thereof, and (2) a brief statement of the intended uses of the device and relevant warnings, precautions, side effects, and contraindications... "

    However, the reverse argument is that 801.109 applies to any prescription device, and that requires labeling, including the risk statement for marketing; the 510(k) submission form asks for a Rx or OTC choice; and the 510(k) clearance letter includes the following verbiage: "You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); ..."

    I look forward to the feedback from this community on this topic. Thank you in advance!

  • 2.  RE: Abbreviated statement/brief summary

    Posted 19-Oct-2017 16:55
    I think they are technically required for restricted devices - which is not directly aligned with PMA/510(k). I have worked with a handful of 510(k) products over the years that were restricted, and the brief summary applied to them. Generally these were called out either in the product code description or in the clearance letter.

    As for "other" 510(k) devices, a brief summary per se wouldn't be required. However, you would need to present some type of fair balance (a term I use reluctantly because it comes from the drug side and doesn't directly translate to devices) in that you can't simply say all the great things your product does without some representation of the known risks. Companies do all sorts of things with this, from simply say "see the IFU" to listing a few common risks, to using the same type of brief summary they use on restricted devices.


    Ginger Glaser RAC
    Vice-President, Engineering