From an FDA newsletter:
The Food and Drug Administration (FDA) joins the Medical Device Single Audit Program’s Regulatory Authority Council in encouraging medical device manufacturers to participate in the Medical Device Single Audit Program (MDSAP) Pilot. The Medical Device Single Audit Program is expected to begin transition to full implementation on January 1, 2017.
What is Medical Device Single Audit Program (MDSAP)?
As envisioned by the International Medical Device Regulators Forum (IMDRF), the FDA developed MDSAP in collaboration with regulatory authorities from Australia, Brazil, Canada, and Japan. IMDRF recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale.
MDSAP enables medical device manufacturers to contract with an MDSAP-authorized Auditing Organization (AO) to conduct a single audit against the relevant medical device regulatory requirements of all fully participating regulatory authorities. For more information about the Medical Device Single Audit Program, please visit the FDA MDSAP Pilot Webpage.
In an effort to help inform the medical device manufacturing community about MDSAP, the FDA posted ten new medical device education modules to the CDRH Learn Program website.
What is CDRH Learn?
CDRH Learn is a multimedia catalog of online educational modules intended to provide information about medical device laws, regulations, and policies that is comprehensive, interactive, and easily accessible. The format for each topic is chosen to present the information in the most effective way possible.