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Third-party inspections

This article was originally published in The Gray Sheet

Executive Summary

Sen. Edward Kennedy (D-Mass.) will monitor the progress of the U.S./EU mutual recognition agreement (MRA) program before committing to any proposal authorizing third-party inspections of medical device manufacturers, HELP Committee staff suggests. Third-party inspection and review provisions within the Greenwood/Eshoo device reform measure (HR 3580) were chief obstacles to device user fee passage as part of the PDUFA reauthorization package currently awaiting the President's signature (1"The Gray Sheet" May 27, 2002, p. 3). Although industry proponents, including AdvaMed, still hope to fasten user fees to Greenwood/Eshoo, HELP staffers indicate Kennedy remains opposed to third-party reforms without evidence of their benefit. Among issues to be resolved are whether third-party inspections can be conducted while avoiding conflicts of interest. The General Accounting Office has indicated that data are insufficient for analysis of third-party and reuse issues requested by Kennedy earlier this year...

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