[Federal Register Volume 81, Number 157 (Monday, August 15, 2016)]
[Notices]
[Pages 54102-54104]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19402]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-0218]
Premarket Notification Submissions for Bipolar Electrosurgical
Vessel Sealers for General Surgery; 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 guidance entitled ``Premarket Notification
(510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for
General Surgery.'' FDA has developed this guidance document to assist
industry in preparing premarket notification (510(k)) submissions for
bipolar electrosurgical vessel sealers intended for use in general
surgery.
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'').
[[Page 54103]]
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-2014-D-0218 for ``Premarket Notification (510(k)) Submissions for
Bipolar Electrosurgical Vessel Sealers for General Surgery.'' 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 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 (510(k)) Submissions for Bipolar
Electrosurgical Vessel Sealers for General Surgery'' 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: Jismi Johnson, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1524, Silver Spring, MD 20993-0002, 301-796-6424.
SUPPLEMENTARY INFORMATION:
I. Background
FDA has developed this guidance document to assist industry in
preparing premarket notification (510(k)) submissions for bipolar
electrosurgical vessel sealers intended for use in general surgery.
These devices are designed to seal isolated blood and lymphatic vessels
for hemostasis (as an alternative to ties) through the use of high-
frequency electrical current between two electrodes in close proximity.
The scope of this document is limited to the class II electrosurgical
devices and accessories classified under 21 CFR 878.4400,
Electrosurgical cutting and coagulation device and accessories. This
generic type of device includes bipolar vessel sealing instruments,
associated electrosurgical generators, and accessories for use in open
and minimally invasive general surgical procedures. This guidance is
intended only to address bipolar electrosurgical vessel sealers that
have general indications for use in general surgery.
In the Federal Register of March 24, 2014 (79 FR 16009), FDA
announced the availability of the draft guidance. Interested persons
were invited to comment by June 23, 2014. Four sets of comments were
received. FDA reviewed and considered all the public comments received
and revised sections of the guidance, where applicable.
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 (510(k)) Submissions
for Bipolar Electrosurgical Vessel Sealers for General Surgery. 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
(510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for
General Surgery'' may send an email request to [email protected] to receive an electronic copy of the document.
Please use the document number 1300048 to identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
This 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 21
CFR 807, subpart E have been approved under OMB control number 0910-
0120; the collections of information in 21 CFR part 820 have been
approved under OMB control number 0910-0073; the collections of
information in 21 CFR part 801 have been approved under OMB control
number 0910-0485; the collections of information in 21 CFR part 58 have
been approved under OMB control number 0910-0119; and the collections
of information in the guidance document ``Requests for Feedback on
Medical Device Submissions: The Pre-Submission Program and Meetings
with Food and Drug Administration Staff'' have been
[[Page 54104]]
approved under OMB control number 0910-0756.
Dated: August 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-19402 Filed 8-12-16; 8:45 am]
BILLING CODE 4164-01-P