Third-party inspector program goes international

FDA and Canadian counterpart Health Canada are developing a pilot program to allow third-party auditors to conduct inspections that simultaneously assess device company compliance with FDA and Canadian manufacturing regulations. "The idea is that these auditing organizations can do one inspection that will fulfill both Canada's requirements and the FDA's requirements," said Bill Sutton, deputy director of CDRH's Division of Small Manufacturers, International & Consumer Assistance, Sept. 19. FDA would like to expand the program to the EU so that one site visit could cover "three or four regulatory requirements"...