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Foreign device inspections up 30% in FY 1995, but import bans drop 30%.

This article was originally published in The Gray Sheet

Executive Summary

FDA DEVICE EXPORT APPROVAL TIME DOWN 35% TO 10.4 DAYS IN FY 1995, according to figures from the device center's Office of Compliance. The average approval times for export requests for unapproved devices for fiscal year 1995 (ended Sept. 30) marks a 5.6-day decrease from the 16-day average time the Center for Devices and Radiological Health reported in January for calendar year 1994 and an 84% improvement over the calendar year 1993 average of 65 days ("The Gray Sheet" Jan. 30, p. 6).

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