80 FR 76501 - Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings; Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 236 (December 9, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 236 (December 9, 2015)
| Page Range | 76501-76503 | |
| FR Document | 2015-30972 |
[Federal Register Volume 80, Number 236 (Wednesday, December 9, 2015)] [Notices] [Pages 76501-76503] From the Federal Register Online [www.thefederalregister.org] [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
![Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Notices 76501
redacted/blacked out, will be available DEPARTMENT OF HEALTH AND • If you want to submit a comment
for public viewing and posted on HUMAN SERVICES with confidential information that you
http://www.regulations.gov. Submit do not wish to be made available to the
both copies to the Division of Dockets Food and Drug Administration public, submit the comment as a
Management. If you do not wish your written/paper submission and in the
[Docket No. FDA–2015–D–2261] manner detailed (see ‘‘Written/Paper
name and contact information to be
made publicly available, you can Premarket Notification Requirements Submissions’’ and ‘‘Instructions’’).
provide this information on the cover Concerning Gowns Intended for Use in Written/Paper Submissions
sheet and not in the body of your Health Care Settings; Guidance for Submit written/paper submissions as
comments and you must identify this Industry and Food and Drug follows:
information as ‘‘confidential.’’ Any Administration Staff; Availability • Mail/Hand delivery/Courier (for
information marked as ‘‘confidential’’ written/paper submissions): Division of
will not be disclosed except in AGENCY: Food and Drug Administration,
HHS. Dockets Management (HFA–305), Food
accordance with 21 CFR 10.20 and other and Drug Administration, 5630 Fishers
applicable disclosure law. For more ACTION: Notice of availability. Lane, Rm. 1061, Rockville, MD 20852.
information about FDA’s posting of
SUMMARY: The Food and Drug • For written/paper comments
comments to public dockets, see 80 FR Administration (FDA or Agency) is submitted to the Division of Dockets
56469, September 18, 2015, or access announcing the availability of the Management, FDA will post your
the information at: http://www.fda.gov/ guidance entitled ‘‘Premarket comment, as well as any attachments,
regulatoryinformation/dockets/ Notification Requirements Concerning except for information submitted,
default.htm. Gowns Intended for Use in Health Care marked and identified, as confidential,
Docket: For access to the docket to Settings.’’ FDA is issuing this guidance if submitted as detailed in
to describe the Agency’s premarket ‘‘Instructions.’’
read background documents or the Instructions: All submissions received
electronic and written/paper comments regulatory requirements and the
must include the Docket No. FDA–
received, go to http:// performance testing needed to support
2015–D–2261 for ‘‘Premarket
www.regulations.gov and insert the liquid barrier claims for gowns intended Notification Requirements Concerning
docket number, found in brackets in the for use in health care settings. This Gowns Intended for Use in Health Care
heading of this document, into the guidance is being issued in light of the Settings.’’ Received comments will be
‘‘Search’’ box and follow the prompts public health importance of personal placed in the docket and, except for
and/or go to the Division of Dockets protective equipment in health care those submitted as ‘‘Confidential
Management, 5630 Fishers Lane, Rm. settings and the recognition that Submissions,’’ publicly viewable at
1061, Rockville, MD 20852. terminology used to describe gowns has http://www.regulations.gov or at the
evolved, including by FDA, industry, Division of Dockets Management
FOR FURTHER INFORMATION CONTACT: the standards community, and health between 9 a.m. and 4 p.m., Monday
Zivana Tezak, Center for Devices and care professionals. through Friday.
Radiological Health, Food and Drug DATES: Submit either electronic or • Confidential Submissions—To
Administration, Bldg. 66, Rm. 4544, written comments on this guidance at submit a comment with confidential
Silver Spring, MD 20993, 301–796– any time. General comments on Agency information that you do not wish to be
6206, zivana.tezak@fda.hhs.gov. guidance documents are welcome at any made publicly available, submit your
SUPPLEMENTARY INFORMATION: In the time. comments only as a written/paper
Federal Register of September 9, 2015 ADDRESSES: You may submit comments submission. You should submit two
(80 FR 54292), FDA published a notice as follows: copies total. One copy will include the
of a public workshop with a deadline of information you claim to be confidential
Electronic Submissions with a heading or cover note that states
November 25, 2015, to request
comments on the workshop topics about Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
the proposed standards-based regulatory following way: CONFIDENTIAL INFORMATION’’. The
strategy for NGS tests that produce • Federal eRulemaking Portal: http:// Agency will review this copy, including
www.regulations.gov. Follow the the claimed confidential information, in
results on variation in the human
instructions for submitting comments. its consideration of comments. The
genome. Comments on the public
Comments submitted electronically, second copy, which will have the
meeting topics will inform FDA’s
including attachments, to http:// claimed confidential information
development of such strategies.
www.regulations.gov will be posted to redacted/blacked out, will be available
FDA is reopening the comment period the docket unchanged. Because your for public viewing and posted on http://
for the notice of the public workshop comment will be made public, you are www.regulations.gov. Submit both
until December 24, 2015. The Agency solely responsible for ensuring that your copies to the Division of Dockets
believes that the extension allows comment does not include any Management. If you do not wish your
adequate time for interested persons to confidential information that you or a name and contact information to be
submit comments without significantly third party may not wish to be posted, made publicly available, you can
delaying decisionmaking on these such as medical information, your or provide this information on the cover
mstockstill on DSK4VPTVN1PROD with NOTICES
important issues. anyone else’s Social Security number, or sheet and not in the body of your
Dated: December 3, 2015.
confidential business information, such comments and you must identify this
as a manufacturing process. Please note information as ‘‘confidential.’’ Any
Peter Lurie, that if you include your name, contact information marked as ‘‘confidential’’
Associate Commissioner for Public Health information, or other information that will not be disclosed except in
Strategy and Analysis. identifies you in the body of your accordance with 21 CFR 10.20 and other
[FR Doc. 2015–30937 Filed 12–8–15; 8:45 am] comments, that information will be applicable disclosure law. For more
BILLING CODE 4164–01–P posted on http://www.regulations.gov.
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![Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Notices 76503
have been approved under OMB control • Federal eRulemaking Portal: http:// the claimed confidential information, in
number 0910–0625; the collections of www.regulations.gov. Follow the its consideration of comments. The
information in 21 CFR part 807, subpart instructions for submitting comments. second copy, which will have the
E have been approved under OMB Comments submitted electronically, claimed confidential information
control number 0910–0120; the including attachments, to http:// redacted/blacked out, will be available
collections of information in 21 CFR www.regulations.gov will be posted to for public viewing and posted on
part 803 have been approved under the docket unchanged. Because your http://www.regulations.gov. Submit
OMB control number 0910–0437; the comment will be made public, you are both copies to the Division of Dockets
collections of information in 21 CFR solely responsible for ensuring that your Management. If you do not wish your
part 820 have been approved under comment does not include any name and contact information to be
OMB control number 0910–0073; and confidential information that you or a made publicly available, you can
the collections of information in 21 CFR third party may not wish to be posted, provide this information on the cover
part 801 have been approved under such as medical information, your or sheet and not in the body of your
OMB control number 0910–0485. anyone else’s Social Security number, or comments and you must identify this
Dated: December 3, 2015.
confidential business information, such information as ‘‘confidential.’’ Any
as a manufacturing process. Please note information marked as ‘‘confidential’’
Peter Lurie,
that if you include your name, contact will not be disclosed except in
Associate Commissioner for Public Health information, or other information that
Strategy and Analysis.
accordance with 21 CFR 10.20 and other
identifies you in the body of your applicable disclosure law. For more
[FR Doc. 2015–30972 Filed 12–8–15; 8:45 am] comments, that information will be information about FDA’s posting of
BILLING CODE 4164–01–P posted on http://www.regulations.gov. comments to public dockets, see 80 FR
• If you want to submit a comment 56469, September 18, 2015, or access
with confidential information that you the information at: http://www.fda.gov/
DEPARTMENT OF HEALTH AND do not wish to be made available to the
HUMAN SERVICES regulatoryinformation/dockets/
public, submit the comment as a default.htm.
written/paper submission and in the
Food and Drug Administration Docket: For access to the docket to
manner detailed (see ‘‘Written/Paper
read background documents or the
Submissions’’ and ‘‘Instructions’’).
[Docket No. FDA–2015–N–3015] electronic and written/paper comments
Written/Paper Submissions received, go to http://
Use of Databases for Establishing the Submit written/paper submissions as www.regulations.gov and insert the
Clinical Relevance of Human Genetic follows: docket number, found in brackets in the
Variants; Public Workshop; Reopening • Mail/Hand delivery/Courier (for heading of this document, into the
of Comment Period written/paper submissions): Division of ‘‘Search’’ box and follow the prompts
Dockets Management (HFA–305), Food and/or go to the Division of Dockets
AGENCY: Food and Drug Administration, Management, 5630 Fishers Lane, Rm.
HHS. and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852.
ACTION:Notice of public workshop; • For written/paper comments
reopening of comment period. FOR FURTHER INFORMATION CONTACT:
submitted to the Division of Dockets David Litwack, Center for Devices and
SUMMARY: The Food and Drug Management, FDA will post your Radiological Health, Food and Drug
Administration (FDA) is reopening the comment, as well as any attachments, Administration, Bldg. 66, Rm. 4548,
comment period for the notice of a except for information submitted, Silver Spring, MD 20993, 301–796–
public workshop that appeared in the marked and identified, as confidential, 6697, ernest.litwack@fda.hhs.gov.
Federal Register of September 9, 2015. if submitted as detailed in
‘‘Instructions.’’ SUPPLEMENTARY INFORMATION: In the
In the notice of the public workshop, Federal Register of September 9, 2015
FDA requested comments on the Instructions: All submissions received
must include the Docket No. FDA– (80 FR 54290), FDA published a notice
workshop topics about the use of of a public workshop with a deadline of
databases that contain information 2015–N–3015 for ‘‘Use of Databases for
Establishing the Clinical Relevance of November 25, 2015, to request
linking human genetic variations to comments on the workshop topics about
disease, where such information has Human Genetic Variants.’’ Received
comments will be placed in the docket the use of databases that contain
been curated by qualified professionals, information linking human genetic
to inform regulatory oversight of the and, except for those submitted as
‘‘Confidential Submissions,’’ publicly variations to disease, where such
clinical performance of genetic tests. information has been curated by
The Agency is taking this action in viewable at http://www.regulations.gov
or at the Division of Dockets qualified professionals, to inform
response to requests to allow interested regulatory oversight of the clinical
persons additional time to submit Management between 9 a.m. and 4 p.m.,
Monday through Friday. performance of genetic tests. Comments
comments.
• Confidential Submissions—To on the public workshop topics will
DATES: FDA is reopening the comment submit a comment with confidential inform FDA’s optimization of regulatory
period for the notice of public workshop information that you do not wish to be approaches for next-generation-based in
published September 9, 2015. Submit made publicly available, submit your vitro diagnostics.
either electronic or written comments
mstockstill on DSK4VPTVN1PROD with NOTICES
comments only as a written/paper FDA is reopening the comment period
by December 24, 2015. submission. You should submit two for the notice of the public workshop
ADDRESSES: You may submit comments copies total. One copy will include the until December 24, 2015. The Agency
as follows: information you claim to be confidential believes that the extension allows
with a heading or cover note that states adequate time for interested persons to
Electronic Submissions ‘‘THIS DOCUMENT CONTAINS submit comments without significantly
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The delaying decision making on these
following way: Agency will review this copy, including important issues.
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Document Created: 2015-12-14 13:32:58
Document Modified: 2015-12-14 13:32:58
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. | |
| 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. | |
| FR Citation | 80 FR 76501 |
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