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Registration and listing

This article was originally published in The Gray Sheet

Executive Summary

Direct-to-final rule published in the Sept. 29 Federal Register amends FDA's device regs to exempt distributors of domestic or imported devices from establishment registration and device listing requirements, in accordance with related provisions of the FDA Modernization Act. The rule adds a definition of "initial importers" and clarifies that they remain subject to the requirements. Comments on the regulation, which takes effect Feb. 11, 1999, are due Dec. 14



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