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In Brief: FDA device submission cover sheet

This article was originally published in The Gray Sheet

Executive Summary

FDA device submission cover sheet: Agency begins six-month pilot program "to test the benefits" of a uniform cover sheet for all device applications -- 510(k)s, premarket approval applications and investigational device exemptions. FDA expects the "fill-in-the-blank" document, finalized last summer ("The Gray Sheet" July 18, 1994, p. 29), to improve the efficiency of the review process and to aid manufacturers in meeting application administrative requirements "on the first try." Copies of the cover sheet, along with instructions and a user survey form, were distributed in January to several industry groups...
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