FDA's Premarket Policy For Device Reprocessors Questioned By Congressmen
This article was originally published in The Gray Sheet
Executive Summary
FDA review standards for premarket applications submitted by reprocessors of single-use devices (SUDs) must be clarified to address the issue of one-time reuse versus multiple reuse, House Commerce Committee Chair Thomas Bliley (R-Va.) and Oversight and Investigations Subcommittee Chair Fred Upton (R-Mich.) maintain in a Nov. 1 letter to the agency.
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