FDA TO LAUNCH PILOT PROGRAM WITH HEALTH CANADA FOR THIRD-PARTY INSPECTIONS

The FDA posted a letter on its website Sept. 7 announcing a pilot program for third-party inspections of device manufacturers.

In accordance with the recently signed Security and Prosperity Partnership agreement between Canada, Mexico and the U.S., the FDA and Health Canada are developing a pilot multipurpose audit program (PMAP), the FDA said.

The purpose of the PMAP is to evaluate the effectiveness of performing a single third-party inspection/audit of devicemakers' quality systems that would meet the regulatory requirements of both Canada and the U.S., the agency said.

The FDA letter can be viewed at www.fda.gov/cdrh/ap-inspection/pmap-letter.html (http://www.fda.gov/cdrh/ap-inspection/pmap-letter.html).