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In Brief: Device export proposed rule

This article was originally published in The Gray Sheet

Executive Summary

Device export proposed rule: FDA reopens comment period on its Nov. 27, 1995 proposed rule to allow the export of unapproved devices covered by investigational device exemptions without prior agency review. In a Jan. 7 Federal Register notice, the agency says it is seeking to determine whether the reg "is still needed in light of" export reform legislation enacted in April 1996. Written comments are due by March 10...
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