FDA Recognition of MDSAP Audit Reports

In a letter to industry, dated September 29, 2016, Dr. Carl Fischer, Director of the Office of Compliance at CDRH said that an MDSAP audit generates a standardized MDSAP Audit Report. The report template assures effective documentation to satisfy the reporting requirements of all participating regulatory authorities (including the U.S. FDA). The U.S. Food and Drug Administration (FDA) recognizes MDSAP audit reports as a substitute for FDA Establishment Inspection Reports (EIRs).

You can read the letter at http://www.fda.gov/downloads/MedicalDevices/InternationalPrograms/MDSAPPilot/UCM523315.pdf