[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Recommendations; Draft Guidance for Industry and Food and Drug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the availability of the draft guidance entitled ``Surgical Staplers and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this draft guidance to provide labeling recommendations for surgical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draft guidance is not final nor is it currently in effect.
DATES: Submit either electronic or written comments on the draft
guidance by June 24, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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