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Device clinical trial database

This article was originally published in The Gray Sheet

Executive Summary

Health Industry Manufacturers Association requests in a July 14 letter to FDA a 30-day extension of the comment period pertaining to the agency's June 22 notice seeking input on the feasibility of including medical device clinical trials in a public data bank. FDA held a public meeting July 8 to gather input on the issue (1"The Gray Sheet" July 12, p. 27). Because the agency is required by the FDA Modernization Act to submit a recommendation to Congress on the subject by Nov. 21, FDA may hesitate to extend the current Aug. 23 deadline

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