Notice2021-22042
Surgical Staplers and Staples for Internal Use-Labeling Recommendations; Guidance for Industry and Food and Drug Administration Staff; Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 8, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a final guidance entitled "Surgical Staplers and Staples for Internal Use--Labeling Recommendations." FDA is issuing this guidance to provide labeling recommendations for surgical staplers and staples for internal use. These labeling recommendations are being issued because malfunctions and misuse associated with these devices have resulted in serious adverse events, including deaths.
Full Text
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<title>Federal Register, Volume 86 Issue 193 (Friday, October 8, 2021)</title>
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[Federal Register Volume 86, Number 193 (Friday, October 8, 2021)]
[Notices]
[Pages 56272-56274]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-22042]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-1262]
Surgical Staplers and Staples for Internal Use--Labeling
Recommendations; 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, we, or Agency) is
announcing the availability of a final guidance entitled ``Surgical
Staplers and Staples for Internal Use--Labeling Recommendations.'' FDA
is issuing this guidance to provide labeling recommendations for
surgical staplers and staples for internal use. These labeling
recommendations are being issued because malfunctions and misuse
associated with these devices have resulted in serious adverse events,
including deaths.
DATES: The announcement of the guidance is published in the Federal
Register on October 8, 2021.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, 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.''
[[Page 56273]]
Instructions: All submissions received must include the Docket No.
FDA-2019-D-1262 for ``Surgical Staplers and Staples for Internal Use--
Labeling Recommendations.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
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
``Surgical Staplers and Staples for Internal Use--Labeling
Recommendations'' to the Office of Policy, 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: George Gibeily, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4660, Silver Spring, MD 20993-0002, 301-796-0276.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry and
FDA staff entitled ``Surgical Staplers and Staples for Internal Use--
Labeling Recommendations.'' Surgical staplers for internal use are
specialized prescription devices used to deliver compatible staples to
internal tissues during surgery for resection, transection, and
creating anastomoses. Surgical staplers and staples for internal use
may be indicated for use in a wide range of surgical applications,
including but not limited to gastrointestinal, gynecologic, and
thoracic surgery. FDA developed this guidance because we had become
aware of a large number of adverse events associated with use of both
surgical staplers and staples for internal use. Both device misuse and
device malfunctions are root causes of these adverse events. FDA
believes that these problems may be mitigated by providing specific
information about the risks, limitations, and directions for use in the
labeling for the surgical staplers and staples for internal use.
This guidance is intended to provide recommendations for
information that should be included in the product labeling for
surgical staplers and staples for internal use, including
contraindications, warnings, directions for use, and technical
characteristics and performance parameters. Elsewhere in this issue of
the Federal Register, FDA is announcing the final reclassification of
surgical staplers for internal use from class I to class II with
special controls. Some of the labeling recommendations in this guidance
are intended to provide additional recommendations in order to help
manufacturers comply with the labeling requirements as part of the
special controls for surgical staplers for internal use.
A notice of availability of the draft guidance appeared in the
Federal Register of April 24, 2019 (84 FR 17174). FDA considered
comments received and revised the guidance as appropriate in response
to the comments, including revisions to the contraindications and
warnings to avoid being overly prescriptive and not interfere with
physicians' decision making under practice of medicine where
appropriate. Revisions were also made to refine the directions for use
and technical characteristics recommendations in response to feedback,
as also described in the final reclassification of surgical staplers
for internal use announced elsewhere in this issue of the Federal
Register. FDA also added the relevant special controls language in
order to make it clear what are requirements under the special controls
and what are further clarifying recommendations.
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 ``Surgical Staplers and Staples for Internal
Use--Labeling Recommendations.'' 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.
II. 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 <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>. This guidance document is also
available at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Persons unable to download an
electronic copy of ``Surgical Staplers and Staples for Internal Use--
Labeling Recommendations'' may send an email request to <a href="/cdn-cgi/l/email-protection#eeadaabca6c3a99b878a8f808d8bae888a8fc086869dc0898198"><span class="__cf_email__" data-cfemail="89cacddbc1a4cefce0ede8e7eaecc9efede8a7e1e1faa7eee6ff">[email protected]</span></a> to receive an electronic copy of the document.
Please use the document number 18013 and complete title to identify the
guidance you are requesting.
III. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction
[[Page 56274]]
Act of 1995 (44 U.S.C. 3501-3521) is not required for this guidance.
The previously approved collections of information are subject to
review by OMB under the PRA. The collections of information in the
following FDA regulations have been approved by OMB as listed in the
following table:
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21 CFR part Topic OMB control No.
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807, subpart E.................. Premarket 0910-0120
Notification.
800, 801, and 809............... Medical Device 0910-0485
Labeling
Regulations.
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Dated: October 4, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-22042 Filed 10-7-21; 8:45 am]
BILLING CODE 4164-01-P
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