The international Medical Device Single Audit Program (MDSAP) to coordinate manufacturing facility inspections across 5 countries is not securing much participation from industry, much to the chagrin of the FDA. Only 45 manufacturing sites expressed interest in joining the program in its first year, out of a goal of 330 sites by the end of 2016.
"Program participation by medical device manufacturers appears to be the primary challenge at the mid-pilot review. Manufacturer participation is vital for the success of the program," the FDA said in status report on the program.
Full implementation of MDSAP is expected to occur in 2017, but nothing is guaranteed, for the pilot phase is designed to "confirm the proof-of-concept," the FDA says. A significant shortfall in participation would be an embarrassment to the agency and show inability to secure buy-in from the companies that it regulates.
Participation is voluntary during the pilot phase, but an FDA spokesman warned that "at some point following completion of the pilot, at least one regulatory authority is strongly considering making MDSAP mandatory" in an email to FierceMedicalDevices.
The other participating regulatory authorities are from Australia, Japan, Brazil and Canada. They have work to do in the recruitment of new facilities too.
The goal of MDSAP is to reduce the number of inspections by enabling a single regulatory audit to provide information on compliance with the regulations of the 5 medical device markets, including the U.S. It is a central pillar of the strategy of regulatory convergence being promoted by global bodies like the International Medical Device Regulators Forum.
Private firms known as "certified bodies" are being recruited to carry out the audits. Certified bodies like the BSI Group are commonly used in Europe to conduct tests for the CE marking of devices. Only those accredited by the Standards Council of Canada and recognized by the Canadian Medical Devices Conformity Assessment System are eligible to participate in MDSAP.
The status report says that as of July 2015, 6 certified bodies have received initial authorization to conduct MDSAP audits. In addition, two have completed the prerequisites for official recognition, such as the performance of an audit witnessed by representatives of the participating regulatory authorities. They now await a decision on final recognition from an MDSAP council.
Ultimately though, the certified bodies need a sufficient number of facilities to inspect. The main incentive for U.S. manufacturers to participate is that the FDA will accept the MDSAP pilot audit as substitute for its routine biennial inspections.
- read the status report (PDF)
- here's some helpful background about MDSAP from the FDA
Editor's Note: The news from an FDA spokesman that the program may not be voluntary in some countries in the future was added to the article.