DRW Monthly
July 2007
Issue No. 8
Review of FDA/Health Canada's Pilot Multipurpose Audit Program
The US Food and Drug Administration (FDA) and the Therapeutic Products Directorate of Health Canada (HC) initiated the Pilot Multipurpose Audit Program (PMAP) in September 2006 to allow qualified auditing organizations to perform a single inspection/audit of medical device manufacturers’ quality management systems that can be used by both agencies. Under the PMAP, the two agencies will evaluate the effectiveness of third-party inspections by both the FDA’s Accredited Persons (AP) Inspection Program and the HC’s Third Party Auditing Organizations, also known as the Canadian Medical Devices Conformity Assessment System (CMDCAS), to ensure that they meet the regulatory requirements of both countries. The PMAP is part of a broader collaborative effort to achieve regulatory cooperation between the US and Canada as reflected in the 2003 Memorandum of Understanding (MOU) between the FDA and the HC’s Health Products and Food Branch as well as a wider governmental initiative among the US, Canada and Mexico with the signing of the Security and Prosperity Partnership of North America (SPP) in 2005. Both the MOU and the SPP aim to strengthen and enhance the exchange of information among participating countries in order to reduce trade barriers and promote economic growth.
The primary goal of the PMAP program is to reduce the audit burden for medical device manufacturers. Although the inspections/audits still encompass two separate but similar sets of requirements (ISO 13485:2003 and related Canadian Medical Devices Regulations/US Quality System Regulation 21 CFR Part 820), the FDA and Health Canada believe that inspection-related manufacturing interruptions will be minimized and cost savings will be increased for device manufacturers when one auditing organization conducts the inspections/audits simultaneously. The FDA and HC plan to initially assess the program to identify best practices and areas for improvement in the conduct of multipurpose audits/inspections by early 2008. Some of the key indicators by which the agencies will be measuring the program’s success will be 1) the level of manufacturer and auditing organization participation, and; 2) the ability of auditing organizations to demonstrate pre-audit/inspection planning, documentation review, on-site assessment and conformance with FDA AP and HC CMDCAS program requirements.
Device manufacturers are eligible to participate in the PMAP if they comply with the following requirements:
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