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FDA, Health Canada Agree to Joint Inspection Program


FDA has entered into an agreement with Health Canada for a pilot multipurpose audit program that could boost the use of third-party inspections. CDRH director Daniel Schultz made the announcement at the Regulatory Affairs Professionals Society (RAPS) annual meeting in October.

Plant inspections for Canada are done almost exclusively by third parties. FDA has been pushing for more U.S. firms to use the third-party inspection program authorized in the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). Therefore, said Schultz, a joint agreement with Canada makes sense. U.S. firms selling products in Canada will need a third-party inspection anyway, so it could make sense to have that third party conduct an FDA inspection at the same time, he said.

“This is the wave of the future,” Schultz said. “We want this to succeed. Doing so many inspections for so many different countries is not the best use of resources. The Accredited Persons program is not dead. We are trying to revive it.”

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