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NEWS TRENDS

In the fall, FDA and Health Canada launched a pilot program allowing authorized third-party inspectors to cover U.S. and Canadian requirements in a single inspection. It was viewed as a step toward eventually having a single authority inspect for worldwide requirements, or something close to it, which industry has said it wants.

So, through March, how many U.S. firms had expressed interest in taking advantage of the program? One.

This was reported by Larry Kessler at the AAMI/FDA International Conference on Medical Device Standards and Regulation. Kessler is director of CDRH’s Office of Science and Engineering Laboratories and chair of the Global Harmonization Task Force.

Kessler said that CDRH obtained a list from Health Canada of all U.S. plants it plans to inspect in 2007, and sent a note offering the joint inspection to all firms whose plants are also on the list for an FDA inspection this year, a total of about 150. Almost all Canadian inspections are done by third parties, so these firms would have to hire an outside auditor anyway.

He offered two possible explanations for the lack of interest. One, firms may already be under contract for 2007 with a Canadian third-party inspector who is not authorized to do simultaneous U.S. inspections, and thus don’t want to break their contracts and go through the process of finding someone else. Two, and more foreboding, there may be a perception that “if you do badly [on a multination inspection], you won’t be able to market your product anywhere in the world. That’s not the way it should work. Yet, it’s a legitimate fear.”