Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings; Guidance for Industry and Food and Drug Administration Staff; Availability, 76501-76503 [2015-30972]
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Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Notices
redacted/blacked out, will be available
for public viewing and posted on
https://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
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://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 https://
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.
FOR FURTHER INFORMATION CONTACT:
Zivana Tezak, Center for Devices and
Radiological Health, Food and Drug
Administration, Bldg. 66, Rm. 4544,
Silver Spring, MD 20993, 301–796–
6206, zivana.tezak@fda.hhs.gov.
In the
Federal Register of September 9, 2015
(80 FR 54292), FDA published a notice
of a public workshop with a deadline of
November 25, 2015, to request
comments on the workshop topics about
the proposed standards-based regulatory
strategy for NGS tests that produce
results on variation in the human
genome. Comments on the public
meeting topics will inform FDA’s
development of such strategies.
FDA is reopening the comment period
for the notice of the public workshop
until December 24, 2015. The Agency
believes that the extension allows
adequate time for interested persons to
submit comments without significantly
delaying decisionmaking on these
important issues.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
Dated: December 3, 2015.
Peter Lurie,
Associate Commissioner for Public Health
Strategy and Analysis.
[FR Doc. 2015–30937 Filed 12–8–15; 8:45 am]
BILLING CODE 4164–01–P
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Jkt 238001
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.
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:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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 https://www.regulations.gov.
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• 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
https://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 https://
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
E:\FR\FM\09DEN1.SGM
09DEN1
76502
Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Notices
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://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 https://
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 selfaddressed 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:
mstockstill on DSK4VPTVN1PROD with NOTICES
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
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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 § 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
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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 presubmission 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 https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://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
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
E:\FR\FM\09DEN1.SGM
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Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–3015]
Use of Databases for Establishing the
Clinical Relevance of Human Genetic
Variants; Public Workshop; Reopening
of Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
reopening of comment period.
ACTION:
The Food and Drug
Administration (FDA) is reopening the
comment period for the notice of a
public workshop that appeared in the
Federal Register of September 9, 2015.
In the notice of the public workshop,
FDA requested comments on the
workshop topics about the use of
databases that contain information
linking human genetic variations to
disease, where such information has
been curated by qualified professionals,
to inform regulatory oversight of the
clinical performance of genetic tests.
The Agency is taking this action in
response to requests to allow interested
persons additional time to submit
comments.
SUMMARY:
FDA is reopening the comment
period for the notice of public workshop
published September 9, 2015. Submit
either electronic or written comments
by December 24, 2015.
ADDRESSES: You may submit comments
as follows:
mstockstill on DSK4VPTVN1PROD with NOTICES
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
VerDate Sep<11>2014
18:21 Dec 08, 2015
Jkt 238001
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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 https://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–N–3015 for ‘‘Use of Databases for
Establishing the Clinical Relevance of
Human Genetic Variants.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://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
PO 00000
Frm 00061
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76503
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
https://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
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://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 https://
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.
FOR FURTHER INFORMATION CONTACT:
David Litwack, Center for Devices and
Radiological Health, Food and Drug
Administration, Bldg. 66, Rm. 4548,
Silver Spring, MD 20993, 301–796–
6697, ernest.litwack@fda.hhs.gov.
In the
Federal Register of September 9, 2015
(80 FR 54290), FDA published a notice
of a public workshop with a deadline of
November 25, 2015, to request
comments on the workshop topics about
the use of databases that contain
information linking human genetic
variations to disease, where such
information has been curated by
qualified professionals, to inform
regulatory oversight of the clinical
performance of genetic tests. Comments
on the public workshop topics will
inform FDA’s optimization of regulatory
approaches for next-generation-based in
vitro diagnostics.
FDA is reopening the comment period
for the notice of the public workshop
until December 24, 2015. The Agency
believes that the extension allows
adequate time for interested persons to
submit comments without significantly
delaying decision making on these
important issues.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\09DEN1.SGM
09DEN1
]]>Agencies
[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: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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 https://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 https://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: https://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 https://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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at https://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 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
[[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
