Medical Devices

Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings - January 21, 2016

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 will hold a webinar for industry to review the Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings guidance document. The webinar is also intended to help manufacturers and other interested stakeholders understand the information provided in this final guidance document.

Following a brief presentation, the FDA will respond to manufacturers' questions regarding the draft guidance document.

FDA Webinar to discuss the Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings - January, 21, 2016

We welcome your questions about this final guidance, so please mark your calendars to participate. No registration is required.

Webinar Details:
Date: January 21, 2016
Time: 1:00 -2:30 PM, Eastern Time.

To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar.

NOTE: You must dial-in to hear the presentation and ask questions:
Dial: 888-566-7703, passcode: 5643932
International Callers Dial: 1-603-395-0068

To view the slide presentation during the webinar:
https://www.mymeetings.com/nc/join.php?i=PW6190659&p=5643932&t=c
Conference number: PW6190659
Audience passcode: 5643932

Following the conference, a transcript, audio recording and slides will be available at the Medical Device Webinars and Stakeholder Calls page.

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 dice@fda.hhs.gov

Food and Drug Administration
Center for Devices and Radiological Health

Page Last Updated: 01/28/2016
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