The U.S. Food and Drug Administration (FDA) has now provided access to presentations from the recent MDSAP Stakeholder Day, giving interested parties insight into the latest developments in the Medical Device Single Audit Program (MDSAP).
Established by the International Medical Device Regulators Forum (IMDRF), the MDSAP allows recognized auditing organizations to conduct a single audit of a medical device manufacturer’s facility that meets the regulatory requirements of all MDSAP-participating countries. Aside from the FDA, other countries that participate in MDSAP include Australia, Brazil, Canada and Japan. Representatives from the World Health Organization (WHO) Prequalification of In Vitro Diagnostics Programme and from the European Union are designated as official observers to MDSAP discussions.
Held in early December, the MDSAP Stakeholder Day brought together representatives from MDSAP regulators as well as approximately 200 participants from trade organizations and device manufacturers. The presentations posted to the FDA’s website include updates on the status of MDSAP accredited auditing organizations, as well as individual presentations by each of the MDSAP participating regulators.