- January 20, 2016
07:00 PM - 07:00 PM EST
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. On December 9, 2015, the U.S. Food and Drug Administration issued the final version of the guidance document, “Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings.”
This guidance clarifies and describes the premarket regulatory requirements for gowns regulated under 21 CFR 878.4040 and the performance testing needed to support liquid barrier claims for gowns intended for use in health care settings.
The FDA held a webinar for industry to review the Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings guidance document. The webinar was also intended to help manufacturers and other interested stakeholders understand the information provided in this final guidance document.
Following a brief presentation, the FDA responded to manufacturers' questions regarding the draft guidance document.
If you have any questions, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2014, 301-796-7100 or firstname.lastname@example.org
Food and Drug Administration
Center for Devices and Radiological Health