Today, 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.” 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.
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.
Gowns are considered Class I devices, exempt from premarket notification under 21 CFR 878.4040(b)(2), subject to the limitations in 21 CFR 878.9, if all of the following factors for a gown exist:
• It is labeled as a gown other than a surgical gown (e.g., isolation gown);
• It is not described in its labeling as a surgical gown; and
• If it has statements relating to barrier protection claims, such statements are for only minimal or low barrier claims to show that its intended use is as a nonsurgical gown.
• It is labeled as a gown other than a surgical gown (e.g., isolation gown);
• It is not described in its labeling as a surgical gown; and
• If it has statements relating to barrier protection claims, such statements are for only minimal or low barrier claims to show that its intended use is as a nonsurgical gown.
Gowns are considered a Class II device under 21 CFR 878.4040(b)(1) and are subject to premarket notification if a gown:
• is labeled as such; (e.g., “surgical gown” or “surgical isolation gown”)
• is described as such in its labeling; (e.g., this gown is suitable as a surgical gown”)
• has statements relating to moderate or high level barrier protection (e.g. ANSI/AAMI Level 3 or 4 barrier protection claims); and/or
• has statements that it is intended for use during sterile procedures (e.g. distributed in sterile package).
• is labeled as such; (e.g., “surgical gown” or “surgical isolation gown”)
• is described as such in its labeling; (e.g., this gown is suitable as a surgical gown”)
• has statements relating to moderate or high level barrier protection (e.g. ANSI/AAMI Level 3 or 4 barrier protection claims); and/or
• has statements that it is intended for use during sterile procedures (e.g. distributed in sterile package).
For gowns that are considered a Class II device under 21 CFR 878.4040(b)(1) and subject to premarket notification, manufacturers should include the following in their 510(k) submission:
1. Evidence that the gown complies with the claimed barrier performance criteria of the currently FDA-recognized version of ANSI/AAMI PB70, or equivalent standard. ANSI/AAMI PB70 establishes physical performance and documentation requirements for gowns and their materials.
2. Performance test data to demonstrate that the gown is an effective barrier in accordance with ANSI/AAMI PB70 barrier performance specifications. Barrier performance testing should be completed on the final, finished, pre-shipment gown, or at the end of the stated shelf life of the gown, as applicable, if the gown is reusable.
3. Representative engineering drawing(s), schematics, illustrations and/or figures of the gown that are clear, legible, labeled with the barrier protection levels of the gown, and include dimensions and the location of the critical and non-critical zones.
4. Sample labeling that clearly identifies the level of liquid barrier protection per ANSI/AAMI PB70.
5. Sample labeling that includes the direction(s) for use and indication(s) for use.
2. Performance test data to demonstrate that the gown is an effective barrier in accordance with ANSI/AAMI PB70 barrier performance specifications. Barrier performance testing should be completed on the final, finished, pre-shipment gown, or at the end of the stated shelf life of the gown, as applicable, if the gown is reusable.
3. Representative engineering drawing(s), schematics, illustrations and/or figures of the gown that are clear, legible, labeled with the barrier protection levels of the gown, and include dimensions and the location of the critical and non-critical zones.
4. Sample labeling that clearly identifies the level of liquid barrier protection per ANSI/AAMI PB70.
5. Sample labeling that includes the direction(s) for use and indication(s) for use.
FDA Webinar to discuss the Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings - [January, 21, 2016]
On January 21, 2016, 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 and answer questions. We welcome your questions about this final guidance, so please mark your calendars to participate. No registration is required.
On January 21, 2016, 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 and answer questions. 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 -2:00 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
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/
Passcode: 5643932
https://www.mymeetings.com/nc/
Passcode: 5643932
Following the conference, a transcript, audio recording and slides will be available at: http://www.fda.gov/
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
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