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"Catch up" 510k

Discussion in 'Medical Devices (21 CFR Part 820)' started by Emilia, Sep 13, 2016.

  1. Emilia

    Emilia New Member

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    Hello! I am looking for some input on the idea of a "catch up" 510k. When you have made several minor changes that only required a letter to file, but you want to update your 510k to show the accumulated changes- how is this handled? How is it viewed by the FDA
     
  2. yodon

    yodon Active Member

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    Regulatory isn't really my area but maybe this gets the ball rolling a little.

    Have you seen the recent draft guidance: https://www.regulations.gov/document?D=FDA-2016-D-2021-0002

    In it, they do talk about an evaluation of the cumulative impact of changes since the most recently cleared 510(k).
     
    Atul Khandekar likes this.
  3. Vintage Goose

    Vintage Goose Active Member

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    Atul Khandekar likes this.
  4. Al Weisenborn

    Al Weisenborn New Member

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    I believe that a Catch-up 510(k) is potentially very risky for the organization filing it. Should the 510(k) be put on hold for questions, as the majority are, you are enjoined against marketing your product in the notification letter. Now what do you do? Do you stop manufacturing, marketing and sales? ---Unlikely. Now you have placed yourself at great regulatory risk. Now, it is true that during an inspection this serious violation will probably be missed and even if discovered not forcefully dealt with.

    Wouldn't be better to declare that your are marketing a new product, change the name, and rollup all the changes in a traditional 510(k)? The costs are essentially identical but compliance risk mitigated.
     

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