Put simply, the Medical Device Single Audit Program (MDSAP) isn't going anywhere when its pilot project ends in 2016, Kim Trautman, associate director, international affairs of the Office of the Center Director of CDRH at the US Food and Drug Administration (FDA), told attendees of RAPS' Regulatory Convergence on Wednesday.
MDSAP is the international consortium of five regulators from the US, Australia, Japan (which came on board in June), Brazil and Canada looking to transform and simplify the way device manufacturer audits are conducted via a pilot program through December 2016.
"While it's a pilot, this is not going away," Trautman said. "There have been laws and legislation changed to accommodate this pilot – and I'm here to tell you that when the pilot ends, we're going fully operational."
As far as concerns that MDSAP still wasn't attracting enough manufacturers in the pilot and that it wouldn't reach the 330 it hoped would participate, Trautman said the cause for their reluctance might be "fear of the unknown and change, or a lack of understanding of the program."
Another reason companies may not have signed on yet may be linked to the EU's inability to officially participate with the five other regulators, which Trautman called "the elephant in the room." She explained that because the pilot involves the transfer of lots of confidential company information, it would be too difficult to sign up all 28 member states of the EU. Still, the EU and the WHO's Prequalification of In Vitro Diagnostics (IVDs) Programme are acting as official observers and Trautman noted a number of ways that the EU is participating.
Most recently MDSAP released its mid-pilot report, which in addition to finding a lack of participation, also found that as of 23 July, 2015, only 45 manufacturing sites have requested to participate in the program.
Trautman noted that although the program will continue beyond its pilot, FDA does not want the program to be written into law because of the other countries involved.
The audits involved in the program, which sometimes include regulators observing the auditing organizations at the manufacturing site, no longer use a previous audit time calculation, which is based on the number of employees at the site, Trautman said, noting that FDA doesn't believe it to be risk-based.
"Yes it might be a day or two more compared to just one auditor coming in," Trautman said of the new audits, also noting the upside of having the audit count for multiple markets in some cases. FDA previously said it would accept the MDSAP audit reports as a substitute for routine inspections, though inspections conducted "for cause" by FDA will not be affected by the program, Trautman said.
"We have also committed to not issue any warning letters during the pilot to qualm fears further as this is a learning period," Trautman said.
Angie Combs, technical manager at the auditor BSI, who said she's actually conducted a few audits, noted that the biggest difference in report writing is the grading of the non-conformities. A grading of 1-3 is considered minor, while three non-conformities of 4 will require an unannounced audit as well as any non-conformity of a score of 5.
"We have found the scoring of the NCs [nonconformities] to be questioned by clients," a Combs slide said. "They think it's a judgment of their QMS [quality management system] rather than what it actually is, a score of lack of implementation or information."