[Federal Register Volume 84, Number 79 (Wednesday, April 24, 2019)]
[Notices]
[Pages 17174-17176]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08259]


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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Recommendations; Draft Guidance for Industry and Food and Drug 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 or Agency) is announcing 
the availability of the draft guidance entitled ``Surgical Staplers and 
Staples for Internal Use--Labeling Recommendations.'' FDA is issuing 
this draft guidance to provide labeling recommendations for surgical 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. This 
draft guidance is not final nor is it currently in effect.

DATES: Submit either electronic or written comments on the draft 
guidance by June 24, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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 17175]]

    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.
     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.gpo.gov/fdsys/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.
    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 draft 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: R. Dale Rimmer, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. G425, Silver Spring, MD 20993-0002, 240-402-4828.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft 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 has 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.
    The draft guidance, when finalized, will 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 a proposed reclassification of 
surgical staplers for internal use from class I to class II with 
special controls. If the reclassification is finalized, some of the 
labeling recommendations in this guidance may be required as part of 
the special controls for surgical staplers for internal use. As such, 
FDA also intends to utilize this draft guidance, when finalized, to 
provide recommendations to help manufacturers comply with any labeling 
special controls identified in the final reclassification order.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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. This guidance 
is not subject to Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the draft 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. 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 [email protected] to receive an electronic 
copy of the document. Please use the document number 18013 to identify 
the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information. 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 
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.

[[Page 17176]]

 
801..........................  Medical Device                  0910-0485
                                Labeling Regulations.
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    Dated: April 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-08259 Filed 4-23-19; 8:45 am]
 BILLING CODE 4164-01-P