Medical Devices

Announcement: Completion of the pilot Multipurpose Audit Program (pMAP)

Today, Health Canada (HC) and the U. S. Food and Drug Administration (FDA) announce the successful conclusion of the pilot Multipurpose Audit Program (pMAP). Initiated September, 2006, this pilot was designed to evaluate the effectiveness of performing a single third party inspection/audit of medical device manufacturers’ quality systems.

For some time now, qualified auditing organizations (AOs) have been capable of performing third party audits/inspections of medical device manufacturers’ quality systems that respectively meet the regulatory requirements of the US and Canada. However this opportunity was underutilized. Through the pMAP, FDA and HC hoped to increase awareness of the advantages of multipurpose audits/inspections currently made possible by AOs operating in the FDA’s Accredited Persons (AP) program and HC’s Canadian Medical Devices Conformity Assessment System (CMDCAS).

The pMAP was intended to be a vehicle for further regulatory cooperation between our countries and thereby lead to advantages for industry, regulatory authorities and auditing organizations. These benefits include the reduction of regulatory burden on industry, better use of FDA and HC resources and increase service by APs to their clients. FDA and HC also used these multipurpose audits/inspections as a learning opportunity to acquire a better knowledge of auditing/inspection approaches that support regulatory objectives while minimizing regulatory burden.

Eleven joint audit/inspections were performed under the pilot, of which ten were assessed for program benefit. The data suggests that joint audit/inspections result in a measurable savings of time-in-facility for those medical devices manufacturers that took advantage of this voluntary program. Savings of time in person-days for the majority of audits/inspections ranged from 25 to 58% with an average of 33% less total time spent at the facility when compared to the estimated combined time of previous audits/inspections performed individually to satisfy the respective regulatory requirements of Health Canada and the FDA.

The lessons learned from the pilot will serve to improve the interaction of both regulatory bodies with AOs, as well as with each other and streamline the procedures by which qualified medical device manufacturers can take advantage of similar joint inspection/audits.

Page Last Updated: 11/03/2014
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