[Federal Register Volume 79, Number 56 (Monday, March 24, 2014)]
[Notices]
[Pages 16009-16010]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-06371]
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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Vessel Sealers for General Surgery; Draft Guidance for Industry and
Food and Drug Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Premarket Notification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. This draft guidance is not final nor is it in effect at this
time.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by June 23, 2014.
ADDRESSES: 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requests for a single hard copy of the draft guidance document entitled
``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.
Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Joshua Nipper, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G404, Silver Spring, MD 20993-0002, 301-796-6524.
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,
endoscopic, and laparoscopic general surgical procedures. This guidance
is intended only to address bipolar electrosurgical vessel sealers that
have general indications for use in general surgery.
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 Agency's current thinking on the content
of premarket notification (510(k)) submissions for bipolar
electrosurgical vessel sealers intended for use in general surgery. It
does not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statute
and regulations.
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 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 draft guidance refers to previously approved collections of
information found in FDA regulations. 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 part 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; and the collections of information in 21 CFR parts
801 and 809 have been approved under OMB control number 0910-0485.
V. Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and
[[Page 16010]]
will be posted to the docket at http://www.regulations.gov.
Dated: March 18, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-06371 Filed 3-21-14; 8:45 am]
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