Document ID: FDA-2019-D-1262-0022
Agency: fda
Document Type: Notice
Title: Surgical Staplers and Staples for
Internal Use—Labeling
Recommendations; Guidance for
Industry and Food and Drug
Administration Staff; Availability
Posted Date: 2021-10-08T04:00Z

[Federal Register Volume 86, Number 193 (Friday, October 8, 2021)]
[Notices]
[Pages 56272-56274]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:
     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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     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 https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     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 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 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 https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also 
available at https://www.regulations.gov. Persons unable to download an 
electronic copy of ``Surgical Staplers and Staples for Internal Use--
Labeling Recommendations'' may send an email request to CDRH-Guidance@fda.hhs.gov 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