In the fall, FDA and Health Canada launched a pilot program allowing authorized third-party inspectors to cover US and Canadian requirements in a single inspection. It was viewed as a step toward eventually having a single authority inspect for worldwide requirements, which industry has said it wants. So how many U.S. firms have expressed interest in taking advantage of the program so far? One. This was reported by Larry Kessler, director of CDRH's Office of Science and Engineering Laboratories and chair of the Global Harmonization Task Force, at this week's AAMI/FDA International Conference on Medical Device Standards and Regulation. Kessler said that CRDH 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 inspector anyway. He offered twoÂ possible explanations for the lack of interest. One, firms may already be under contract for 2007 with a Canadian third-party inspectorÂ who is not authorizedÂ to do simultaneous U.S. inspections, and 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 multi-nation 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." There is a disconnect between what industry says it wants and what it seems willing to do. Industry needs to drop the pretense of wanting a single inspection covering multiple authorities if firms aren't willing to participate in pilot programs.
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