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FDA issues FAQs on MDSAP

March 31, 2017

In late March, US FDA released a 36-page document containing frequently asked questions (FAQ) on the Medical Device Single Audit Program (MDSAP). The 96 FAQs are organized around three major areas, General, Assessment related and Audits and contain multiple links back to other documents, including the IMDRF documents. Relationships to WHO, ISO 13485, NRTL and the FDA PMA program are all addressed in the FAQ along with qualification to participate in MDSAP and potential benefits among several other items.

You can access the FAQs at: https://www.fda.gov/downloads/MedicalDevices/UCM430563.pdf

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