Accreditation Scheme for Conformity Assessment (ASCA)

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  • Streamline conformity assessment in device submissions
  • Enhance the FDA’s confidence in test methods and results
  • Decrease the need for additional information related to conformance with a standard
  • Promote consistency, predictability, and efficiency in medical device review
  • Serve as a least burdensome approach to conformity assessment


    Thank you for the updates of schedule M

      Dear Ravindran
      Thank you for your review comments.
      We hope these tips help! Let us know if you have any other questions.

    Fwqrc team, please provide details about revised schedule M and its recommendations

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