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IDE modifications reg

This article was originally published in The Gray Sheet

Executive Summary

Publication of a final version of the rule could be held up until after the Nov. 21 deadline stipulated by the FDA Modernization Act because the Office of Management and Budget has determined that the rule is "significant" and worthy of OMB's review, FDAers say. OMB has 90 days from June 17 to review the rule before it can be issued as a proposed rule in the Federal Register. The rule, which will spell out which modifications may be made to an investigational device exemption product or protocol without FDA notification, is one of eight rules and guidances that the agency's device center had planned for release by September ("The Gray Sheet" June 29, p. 7)



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