IMDRF Aims for Single-Audit Pilot in 2014; Auditor Training to Begin This Summer

Auditors for a new international inspection program will begin training this summer and spring into action next year, a U.S. Food and Drug Administration official revealed at the FDAnews Medical Device Quality Congress in Washington, D.C.

Kimberly Trautman, associate director of international affairs at CDRH, offered details June 2 on the Medical Device Single Audit Program (MDSAP), as part of an update on the International Medical Device Regulators Forum. Trautman chairs IMDRF’s MDSAP committee, which also includes regulators from Canada, Brazil and Australia. Japan is expected to join at the conclusion of an upcoming pilot program.

Under MDSAP, accredited auditors will subcontract to one of the four countries and their audits will then be accepted in any participating nation. The committee has worked to establish formal requirements for the recognition of organizations performing audits, as well as consistent auditor competency and training requirements, Trautman said.

The committee recently posted documents outlining the audit program for a second and last internal comment period, with a June 14 deadline. They are now available for public comment through August. The plan is to finalize MDSAP by October, Trautman said. Auditor training will begin during the public comment period.

The initial goal is to enroll 15 to 17 auditing groups, with more to be added as demand increases, Trautman told conference-goers. The first batch of enrollees will be certified in January 2014, with manufacturers able to participate in pilot audits the following June.

IMDRF members are hoping the single-audit program will benefit countries with shrinking government budgets, Trautman said. “Around the world, we have to do more with less.” One of the best ways to do that is by leveraging regulatory research from other countries, she added.
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