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  • 1.  Refuse to Accept Checklist for 510(k)s

    Posted 30-Apr-2019 13:41
    I am now working on a new 510(k) and I noticed that there is a new version of the RTA Policy for 510(k)s with the newest version dated February 21, 2019. Does anyone know what the exact differences are between the newest version and the version dated January 20, 2018?

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  • 2.  RE: Refuse to Accept Checklist for 510(k)s

    Posted 30-Apr-2019 17:34
    They didn't change the spirit of the checklists, but did change enough wording, references, and a few questions about voluntary standards, that you should use the new version.

    In my opinion.

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    Dolan Mills RAC
    Principal Specialist, Regulatory Affairs
    Bartlett TN
    United States
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    Original Message


  • 3.  RE: Refuse to Accept Checklist for 510(k)s

    Posted 01-May-2019 09:11
    Hi Jean,

    Definitely use the latest version because it has some grammatical and wording corrections, and as Dolan indicated it has incorporated some of the guidance document information from the last couple of years.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


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