Document ID: FDA-2014-D-0217-0001
Agency: fda
Document Type: Notice
Title: Premarket Notification Submissions for Electrosurgical Devices for General Surgery; Draft Guidance for Industry and Food and Drug Administration Staff; Availability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 16008-16009]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-06372]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0217]

Premarket Notification Submissions for Electrosurgical Devices 
for General Surgery; Draft Guidance for Industry and Food and Drug 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availability of the draft guidance entitled ``Premarket Notification 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 Electrosurgical Devices for General Surgery.'' 
FDA has developed this guidance document to assist industry in 
preparing premarket notification (510(k)) submissions for 
electrosurgical devices 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 This draft 
guidance is not final nor is it in effect at this time.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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by June 23, 2014.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requests for a single hard copy of the draft guidance document entitled 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 Electrosurgical 
Devices 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    Submit electronic comments on the draft guidance to http://www.regulations.gov.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 
electrosurgical devices intended for use in general surgery. These 
devices are designed to cut and/or remove tissue and control bleeding 
through the use of high frequency electrical current. For the purpose 
of this guidance, electrosurgical devices may also be called 
radiofrequency devices or high frequency devices. 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.

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 electrosurgical 
devices for 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 Electrosurgical Devices 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 1835 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

[[Page 16009]]

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 will be posted to the docket at http://www.regulations.gov.

    Dated: March 18, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-06372 Filed 3-21-14; 8:45 am]
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