Document ID: FDA-2014-D-0218-0001
Agency: fda
Document Type: Notice
Title: Premarket Notification Submissions for Bipolar Electrosurgical Vessel
Sealers for General Surgery; Draft Guidance for Industry and Food and
Drug Administration Staff; Availability
Posted Date: 2014-03-24T04:00Z

[Federal Register Volume 79, Number 56 (Monday, March 24, 2014)]
[Notices]
[Pages 16009-16010]
From the Federal Register Online via the Government Printing 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Vessel Sealers for General Surgery; Draft Guidance for Industry and 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availability of the draft guidance entitled ``Premarket Notification 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 This draft guidance is not final nor is it in effect at this 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by June 23, 2014.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requests for a single hard copy of the draft guidance document entitled 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    Submit electronic comments on the draft guidance to http://www.regulations.gov.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 CDRH-Guidance@fda.hhs.gov 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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