[Federal Register Volume 80, Number 236 (Wednesday, December 9, 2015)]
[Notices]
[Pages 76501-76503]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-30972]


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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; Guidance for Industry and Food and Drug 
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the guidance entitled ``Premarket Notification 
Requirements Concerning Gowns Intended for Use in Health Care 
Settings.'' FDA is issuing this 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 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 FDA, industry, the standards community, and health care 
professionals.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-D-2261 for ``Premarket Notification Requirements Concerning 
Gowns Intended for Use in Health Care Settings.'' Received comments 
will be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more

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information about FDA's posting of comments to public dockets, see 80 
FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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.

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 23856 at 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) 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 2296 at 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, cover gowns, comfort 
gowns, procedural gowns, and operating room gowns. The Agency has 
defined the term ``surgical gowns'' through existing guidance and 
substantial equivalence decisions to mean ``surgical apparel worn by 
operating room personnel during surgical procedures to protect both the 
surgical patient and the operating room personnel from transfer of 
microorganisms, body fluids, and particulate material.'' 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 market 
place. The purpose of this 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.
    In the Federal Register of June 30, 2015 (80 FR 37275), FDA 
announced the availability of the draft of this guidance. Interested 
persons were invited to comment by August 31, 2015. FDA considered the 
public comments received and revised the guidance, where applicable. 
Multiple comments requested revisions to the terminology used in the 
guidance; however, the intent of the guidance was not to change 
existing terminology as used by the Agency, but rather to clarify and 
describe the premarket regulatory requirements concerning gowns 
intended for use in health care settings. While the focus of any future 
actions on this topic may include discussion on changing terminology, 
such changes would require additional regulatory action and are outside 
the scope of this guidance. Additionally, several comments were 
received regarding the Agency's expectation that submitters submit a 
510(k) within 60 days if they are not currently in compliance with the 
expectations outlined in the guidance. We continue to believe this 
timeframe for submission is appropriate since submitters should already 
have conducted the testing to support their particular liquid barrier 
claims. For the comments received related to specific products, FDA is 
encouraging submitters to contact the review Division directly or 
submit a pre-submission to address these concerns as it is not 
appropriate to address such product-specific concerns in the guidance.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on Premarket Notification Requirements 
Concerning 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 
Requirements Concerning Gowns Intended for Use in Health Care 
Settings'' may send an email request to [email protected] 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

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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.

    Dated: December 3, 2015.
Peter Lurie,
Associate Commissioner for Public Health Strategy and Analysis.
[FR Doc. 2015-30972 Filed 12-8-15; 8:45 am]
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