FDA Issues Guidance Document on Gowns Used in Healthcare Settings

摘要

The U.S. Food and Drug Administration (FDA) will hold a webinar on January 21, 2016, to outline its final guidance document entitled "Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings." This guidance is needed, according to FDA, because "The terminology used to describe gowns has evolved, making it important for both industry and gown users to have a clear and consistent understanding of the terms used to describe the protective ability of gowns."According to FDA, the guidance document clarifies and describes premarket regulatory requirements for gowns as well as performance testing needed to support liquid barrier claims for gowns used in healthcare settings.