The FDA has released the Mid-Pilot Report for the Medical Device Single Audit Program (MDSAP), to provide the current status of the program’s performance goal and objectives.
The goal of the MDSAP pilot is to provide objective evidence that a regulatory audit of a medical device manufacturer conducted by an MDSAP-recognized auditing organization can fulfill the needs of participating regulatory authorities.
The pilot’s objectives include developing the infrastructure, processes, training, and stakeholder commitment necessary to launch the operational phase of the MDSAP in January 2017.
The participating regulatory authorities are the Therapeutic Goods Administration of Australia, Brazil’s Agência Nacional de Vigilância Sanitária, Health Canada, Japan’s Ministry of Health, Labour and Welfare, with the Japanese Pharmaceuticals and Medical Devices Agency, and the United States Food and Drug Administration.
The World Health Organization Prequalification of In Vitro Diagnostics Programme and the European Union are official observers.
