Document ID: FDA-2015-D-2261-0001
Agency: fda
Document Type: Notice
Title: Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Posted Date: 2015-06-30T04:00Z

[Federal Register Volume 80, Number 125 (Tuesday, June 30, 2015)]
[Notices]
[Pages 37275-37276]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16011]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-2261]

Premarket Notification Requirements Concerning Gowns Intended for 
Use in Health Care Settings; Draft Guidance for Industry and Food and 
Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Premarket Notification 
Requirements Concerning Gowns Intended for Use in Health Care 
Settings.'' FDA is issuing this draft guidance to describe the Agency's 
premarket regulatory requirements and the performance testing needed to 
support liquid barrier claims for gowns intended for use in health care 
settings. This draft guidance is being issued in light of the public 
health importance of personal protective equipment in health care 
settings and the recognition that terminology used to describe gowns 
has evolved, including by industry, the standards community, and health 
care professionals. This draft guidance is not final nor is it in 
effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment of this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by August 31, 2015.

ADDRESSES: An electronic copy of the guidance document is available for 
download from the Internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the guidance document entitled 
``Premarket Notification Requirements Concerning Gowns Intended for Use 
in Health Care Settings'' to the Office of the Center Director, 
Guidance and Policy Development, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed 
adhesive label to assist that office in processing your request.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Claverie, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 2508, Silver Spring, MD 20993-0002, 301-
796-6298.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA issued a final rule on June 24, 1988 (53 FR 23874), defining 
``surgical apparel'' under 21 CFR 878.4040. Under this 1988 final rule, 
surgical gowns and surgical masks were classified as Class II subject 
to premarket review under section 510(k) (21 U.S.C. 351) of the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act), and surgical apparel other 
than surgical gowns and surgical masks were classified as Class I also 
subject to 510(k) premarket review requirements. On January 14, 2000, 
FDA issued a final rule (65 FR 2318) to designate as exempt from 
premarket notification requirements surgical apparel other than 
surgical gowns and surgical masks, subject to the limitations of 
exemptions under 21 CFR 878.9, which includes requiring a premarket 
notification for devices intended for a use different from the intended 
use of a legally marketed device in that generic type of device.
    Since the original 1988 final rule, a number of terms have been 
used to refer to gowns intended for use in health care settings 
including, but not limited to, surgical gowns, isolation gowns, 
surgical isolation gowns, nonsurgical gowns, procedural gowns, and 
operating room gowns. In 2004, FDA recognized the consensus standard 
American National Standards Institute/Association of the Advancement of 
Medical Instrumentation (ANSI/AAMI) PB70:2003, ``Liquid barrier 
performance and classification of protective apparel and drapes 
intended for use in health care facilities.'' ANSI/AAMI PB 70 utilized 
new terminology for barrier performance of gowns. This terminology 
described and assessed the barrier protection levels of gowns and other 
protective apparel intended for use in health care facilities, by 
specifying test methods and performance results necessary to verify and 
validate the newly defined levels of barrier protection. The 
definitions and terminology used in this standard are inconsistent with 
FDA's historical definitions of these terms and thus have added 
confusion in the marketplace. The purpose of this draft guidance is to 
clarify and describe the premarket regulatory requirements pertaining 
to gowns regulated under Sec.  878.4040 and the performance testing 
needed to support liquid barrier claims for gowns intended for use in 
health care settings.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance 
represents the Agency's current thinking on performance testing to 
support liquid barrier claims for gowns intended for use in health care 
settings. It does not establish any rights for any person and is not 
binding on FDA or the public. You can use an alternative approach if it 
satisfies the requirements of the applicable statutes and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
downloading an electronic copy from the Internet. A search capability 
for all Center for Devices and Radiological Health guidance documents 
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. Persons 
unable to download an electronic copy of ``Premarket Notification

[[Page 37276]]

Requirements Concerning Gowns Intended for Use in Health Care 
Settings'' may send an email request to CDRH-Guidance@fda.hhs.gov to 
receive an electronic copy of the document. Please use the document 
number 1500025 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 807, subparts A through D 
have been approved under OMB control number 0910-0625; the collections 
of information in 21 CFR part 807, subpart E have been approved under 
OMB control number 0910-0120; the collections of information in 21 CFR 
part 803 have been approved under OMB control number 0910-0437; the 
collections of information in 21 CFR part 820 have been approved under 
OMB control number 0910-0073; and the collections of information in 21 
CFR part 801 have been approved under OMB control number 0910-0485.

V. Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. It is only necessary 
to send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: June 25, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-16011 Filed 6-29-15; 8:45 am]
 BILLING CODE 4164-01-P