The FDA posted a letter on its Web site 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 US, 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 US.
As medical device and diagnostics products become more complex and as demand increases, the chance of errors and inconsistencies in manufacturing escalate. By implementing systematic production and quality controls, manufacturers can eliminate variability that lead to FDA actions, devastating product recalls, and lost market share.
The FDA letter can be viewed online.