The United States and Canada recognize the importance of the role of third parties in the oversight of the medical device industry. Both countries also recognize the benefits of closer regulatory cooperation, as reflected in the 2003 Memorandum of Understanding between the US Food and Drug Administration (FDA) and the Health Products and Food Branch of Health Canada (HC) and the broader government-level Security and Prosperity Partnership (SPP), signed in March 2005. The Pilot Multipurpose Audit Program (PMAP) is an important outcome of this evolving regulatory cooperation.
Qualified auditing organizations (AOs) are now capable of performing third party audits/inspections of medical device manufacturers’ quality systems that will respectively meet the regulatory requirements of the US and Canada. Multipurpose audits/inspections are already taking place under other programs. Through the PMAP, FDA and HC hope 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 is intended to be a vehicle for further regulatory cooperation between our countries and thereby lead to a reduction of regulatory burden on industry. FDA and HC wish to use 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.
The PMAP does not add to, delete from, nor alter previously established and published procedures, guidance, and regulations used by FDA’s AP program or HC’s CMDCAS program.
