Medical Device Single Audit Program: FDA Wants You

By MedTech Intelligence Staff

The agency wants device manufacturers to participate in the MDSAP Pilot.

The Medical Device Single Audit Program (MDSAP) is transitioning to full implementation by January 1, 2017. In anticipation, FDA has set up 10 medical device education modules to help companies learn more about MDSAP. Available in the CDRH Learn section of the FDA website, the modules cover the following areas surrounding MDSAP:

  • Introduction to MDSAP
  • MDSAP management
  • Device marketing authorization and facility registration
  • Measurement, analysis and improvement
  • Adverse events and advisory notices reporting
  • Design and development
  • Production and service controls
  • Purchasing

MDSAP was developed by FDA with regulatory agencies from Australia, Brazil, Canada and Japan. The program enables device companies to contract with an MDSAP-authorized auditing organization to conduct a single audit against relevant device regulatory requirements.

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