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Dropping MDSAP?

Discussion in 'US Medical Device Regulations' started by JustDesign, Mar 13, 2023.

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  1. JustDesign

    JustDesign New Member

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    Anybody know the process for leaving the MDSAP program and going back to standard FDA inspections? Specifics:
    > Do we just terminate the contract with the notified body we're registered with?

    > Is there an FDA form we submit to FDA?

    > Can we just continue to manufacture for USA market once we've informed FDA we're going back to standard program?

    Any advice or experience on this welcome.
     
    JustDesign, Mar 13, 2023
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  2. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Welcome JustDesign!

    Have you asked your Certifying body these questions? I would start by contacting your Certifying Body sales representative.
     
    Jennifer Kirley, Mar 13, 2023
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