CDRH Pushing Industry on PMAP Inspections

Devicemakers that were invited to but did not participate in the joint U.S.-Canadian pilot multipurpose audit program (PMAP) are a priority for FDA inspection, according to an agency director.

Under PMAP, firms audited by an accredited FDA inspector also satisfy the inspection requirements for Health Canada. The program is part of the FDA’s harmonization efforts for medical devices, which allow one inspection to fulfill regulatory requirements for multiple jurisdictions.

The Center for Devices and Radiological Health (CDRH) looked at Health Canada’s list of planned audits for the next year and matched them up with sites the FDA was going to inspect, Timothy Ulatowski, director of CDRH’s Office of Compliance, said. Facilities scheduled for audits by both regulators were requested to participate in PMAP.

“We had a few takers but not enough,” Ulatowski said last week at the FDAnews Medical Device Quality Congress in Cambridge, Mass. “We are going to inspect those people who do not take us up on that one audit.”

The decision is not punishment for manufacturers’ lack of participation, Ulatowski said, because the companies were considered inspection priorities anyway.

To guide the center’s selection criteria for which firms to inspect, the FDA plans to release a draft guidance explaining how the agency will interpret International Organization for Standardization (ISO) audits voluntarily submitted by manufacturers, Ulatowski said.

Under the FDA Amendments Act, the agency is authorized to use submitted audit reports to help determine its inspection priorities.