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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.
     
  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.