[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 76502]]
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
[[Page 76503]]
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]
BILLING CODE 4164-01-P