The FDA isn’t exactly pleased with the turnout of manufacturing sites volunteering to be inspected via the international Medical Device Single Audit Program (MDSAP) in its first-year pilot.
Across five countries, only 45 sites have indicated they’d like to join the program. By the end of 2016, though, the goal is 330.
“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, according to FierceMedicalDevices.
The program is still in pilot phase, but in order to move forward, the FDA needs more participants from the U.S., Australia, Japan, Brazil and Canada. The plan is to reduce the frequency of inspections by developing a regulatory audit.
Private firms known as “certified bodies” will be carrying out the audits. As Fierce reported, “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 FDA and other regulatory authorities are pushing for medical device companies to participate in the pilot, but involvement is voluntary, which makes it difficult apparently. Ultimately, participating would likely make things easier on everyone, though.
Photo: Flickr user hobvias sudoneighm
