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Device export approval streamlining

This article was originally published in The Gray Sheet

Executive Summary

FDA will provide industry with correspondence in about a month outlining further streamlining of its export approval policy for devices bound for European Community member countries, agency staffers say. Changes in the type of safety data required under section 801(e) of the Food, Drug and Cosmetic Act are expected. The agency has said it is likely to use the CE mark of approval in its export approval program ("The Gray Sheet" May 23, p. 16). FDA's Office of Compliance also reports average turn-around times of 20 days for 801(e) clearances and 15 days for certificates for export for the first five months of 1994, an improvement over the 1993 averages Of 65 days and 52 days, respectively

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