81 FR 54100 - Premarket Notification Submissions for Electrosurgical Devices for General Surgery; Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 157 (August 15, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 157 (August 15, 2016)
| Page Range | 54100-54101 | |
| FR Document | 2016-19404 |
[Federal Register Volume 81, Number 157 (Monday, August 15, 2016)] [Notices] [Pages 54100-54101] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-19404] ----------------------------------------------------------------------- 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; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the 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. 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''). 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-0217 for ``Premarket Notification (510(k)) Submissions for Electrosurgical Devices 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. [[Page 54101]] 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 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. 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 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. In the Federal Register of March 24, 2014 (79 FR 16008), FDA announced the availability of the draft guidance. Interested persons were invited to comment by June 23, 2014. A total of six 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 electrosurgical devices 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 Electrosurgical Devices for General Surgery'' may send an email request to [email protected] 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 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 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; the collections of information in 21 CFR part 801 have been approved under OMB control number 0910-0485; 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 approved under OMB control number 0910-0756. Dated: August 9, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-19404 Filed 8-12-16; 8:45 am] BILLING CODE 4164-01-P
![54100 Federal Register / Vol. 81, No. 157 / Monday, August 15, 2016 / Notices
appropriate advisory committee meeting Closed Committee Deliberations: On DATES: Submit either electronic or
link, or call the advisory committee October 27, 2016, the meeting will be written comments on this guidance at
information line to learn about possible closed from 3:35 p.m. to 4:20 p.m. to any time. General comments on Agency
modifications before coming to the permit discussion where disclosure guidance documents are welcome at any
meeting. For those unable to attend in would constitute a clearly unwarranted time.
person, the meeting will also be invasion of personal privacy (5 U.S.C. ADDRESSES: You may submit comments
available via Web cast. The Web cast 552b(c)(6)). The committee will discuss as follows:
will be available at the following link: reports of intramural research programs
and make recommendations regarding Electronic Submissions
https://collaboration.fda.gov/apac1016/.
personnel staffing decisions. Submit electronic comments in the
SUPPLEMENTARY INFORMATION: Agenda: Persons attending FDA’s advisory following way:
On October 27, 2016, the committee will committee meetings are advised that the • Federal eRulemaking Portal: http://
meet by teleconference. In open session, Agency is not responsible for providing www.regulations.gov. Follow the
the committee will hear updates of access to electrical outlets. instructions for submitting comments.
research programs in the Laboratory of FDA welcomes the attendance of the Comments submitted electronically,
Immunobiochemistry of the Division of public at its advisory committee including attachments, to http://
Bacterial, Parasitic and Allergenic meetings and will make every effort to www.regulations.gov will be posted to
Products (DBPAP), Office of Vaccines accommodate persons with disabilities. the docket unchanged. Because your
Research and Review, Center for If you require accommodations due to a comment will be made public, you are
Biologics Evaluation and Research, disability, please contact Janie Kim at solely responsible for ensuring that your
FDA. least 7 days in advance of the meeting. comment does not include any
FDA intends to make background FDA is committed to the orderly confidential information that you or a
material available to the public no later conduct of its advisory committee third party may not wish to be posted,
than 2 business days before the meeting. meetings. Please visit our Web site at such as medical information, your or
If FDA is unable to post the background http://www.fda.gov/ anyone else’s Social Security number, or
material on its Web site prior to the AdvisoryCommittees/ confidential business information, such
meeting, the background material will AboutAdvisoryCommittees/ as a manufacturing process. Please note
be made publicly available at the ucm111462.htm for procedures on that if you include your name, contact
location of the advisory committee public conduct during advisory information, or other information that
meeting, and the background material committee meetings. identifies you in the body of your
will be posted on FDA’s Web site after Notice of this meeting is given under comments, that information will be
the meeting. Background material is the Federal Advisory Committee Act (5 posted on http://www.regulations.gov.
available at http://www.fda.gov/ U.S.C. app. 2). • If you want to submit a comment
AdvisoryCommittees/Calendar/ Dated: August 9, 2016. with confidential information that you
default.htm. Scroll down to the Janice M. Soreth, do not wish to be made available to the
appropriate advisory committee meeting Acting Associate Commissioner, Special
public, submit the comment as a
link. Medical Programs. written/paper submission and in the
[FR Doc. 2016–19338 Filed 8–12–16; 8:45 am]
manner detailed (see ‘‘Written/Paper
Procedure: On October 27, 2016, from Submissions’’ and ‘‘Instructions’’).
1 p.m. to 3:30 p.m., the meeting is open BILLING CODE 4164–01–P
to the public. Interested persons may Written/Paper Submissions
present data, information, or views, Submit written/paper submissions as
orally or in writing, on issues pending DEPARTMENT OF HEALTH AND
follows:
before the committee. Written HUMAN SERVICES • Mail/Hand delivery/Courier (for
submissions may be made to the contact written/paper submissions): Division of
Food and Drug Administration
person on or before October 13, 2016. Dockets Management (HFA–305), Food
Oral presentations from the public will [Docket No. FDA–2014–D–0217] and Drug Administration, 5630 Fishers
be scheduled between approximately Lane, Rm. 1061, Rockville, MD 20852.
2:30 p.m. and 3:30 p.m. Those Premarket Notification Submissions • For written/paper comments
individuals interested in making formal for Electrosurgical Devices for General submitted to the Division of Dockets
oral presentations should notify the Surgery; Guidance for Industry and Management, FDA will post your
contact person and submit a brief Food and Drug Administration Staff; comment, as well as any attachments,
statement of the general nature of the Availability except for information submitted,
evidence or arguments they wish to AGENCY: Food and Drug Administration, marked and identified, as confidential,
present, the names and addresses of HHS. if submitted as detailed in
proposed participants, and an ACTION: Notice of availability. ‘‘Instructions.’’
indication of the approximate time Instructions: All submissions received
requested to make their presentation on SUMMARY: The Food and Drug must include the Docket No. FDA–
or before October 4, 2016. Time allotted Administration (FDA or Agency) is 2014–D–0217 for ‘‘Premarket
for each presentation may be limited. If announcing the availability of the Notification (510(k)) Submissions for
the number of registrants requesting to guidance entitled ‘‘Premarket Electrosurgical Devices for General
speak is greater than can be reasonably Notification (510(k)) Submissions for Surgery.’’ Received comments will be
sradovich on DSK3GMQ082PROD with NOTICES
accommodated during the scheduled Electrosurgical Devices for General placed in the docket and, except for
open public hearing session, FDA may Surgery.’’ FDA has developed this those submitted as ‘‘Confidential
conduct a lottery to determine the guidance document to assist industry in Submissions,’’ publicly viewable at
speakers for the scheduled open public preparing premarket notification http://www.regulations.gov or at the
hearing session. The contact person will (510(k)) submissions for electrosurgical Division of Dockets Management
notify interested persons regarding their devices intended for use in general between 9 a.m. and 4 p.m., Monday
request to speak by October 5, 2016. surgery. through Friday.
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![Federal Register / Vol. 81, No. 157 / Monday, August 15, 2016 / Notices 54101
• Confidential Submissions—To FOR FURTHER INFORMATION CONTACT: document. Please use the document
submit a comment with confidential Jismi Johnson, Center for Devices and number 1835 to identify the guidance
information that you do not wish to be Radiological Health, Food and Drug you are requesting.
made publicly available, submit your Administration, 10903 New Hampshire
IV. Paperwork Reduction Act of 1995
comments only as a written/paper Ave., Bldg. 66, Rm. 1524, Silver Spring,
submission. You should submit two MD 20993–0002, 301–796–6424. This guidance refers to previously
copies total. One copy will include the SUPPLEMENTARY INFORMATION: approved collections of information.
information you claim to be confidential These collections of information are
I. Background subject to review by the Office of
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS FDA has developed this guidance Management and Budget (OMB) under
CONFIDENTIAL INFORMATION.’’ The document to assist industry in preparing the Paperwork Reduction Act of 1995
Agency will review this copy, including premarket notification (510(k)) (44 U.S.C. 3501–3520). The collections
the claimed confidential information, in submissions for electrosurgical devices of information in 21 CFR part 807,
its consideration of comments. The intended for use in general surgery. subpart E have been approved under
These devices are designed to cut and/ OMB control number 0910–0120; the
second copy, which will have the
or remove tissue and control bleeding collections of information in 21 CFR
claimed confidential information
through the use of high-frequency part 820 have been approved under
redacted/blacked out, will be available
electrical current. For the purpose of OMB control number 0910–0073; the
for public viewing and posted on http://
this guidance, electrosurgical devices collections of information in 21 CFR
www.regulations.gov. Submit both
may also be called radiofrequency part 801 have been approved under
copies to the Division of Dockets OMB control number 0910–0485; and
Management. If you do not wish your devices or high-frequency devices. The
scope of this document is limited to the the collections of information in the
name and contact information to be guidance document ‘‘Requests for
class II electrosurgical devices and
made publicly available, you can Feedback on Medical Device
accessories classified under 21 CFR
provide this information on the cover Submissions: The Pre-Submission
878.4400, Electrosurgical cutting and
sheet and not in the body of your Program and Meetings with Food and
coagulation device and accessories.
comments and you must identify this In the Federal Register of March 24, Drug Administration Staff’’ have been
information as ‘‘confidential.’’ Any 2014 (79 FR 16008), FDA announced the approved under OMB control number
information marked as ‘‘confidential’’ availability of the draft guidance. 0910–0756.
will not be disclosed except in Interested persons were invited to Dated: August 9, 2016.
accordance with 21 CFR 10.20 and other comment by June 23, 2014. A total of six
applicable disclosure law. For more Leslie Kux,
sets of comments were received. FDA Associate Commissioner for Policy.
information about FDA’s posting of reviewed and considered all the public
comments to public dockets, see 80 FR [FR Doc. 2016–19404 Filed 8–12–16; 8:45 am]
comments received and revised sections
56469, September 18, 2015, or access of the guidance, where applicable. BILLING CODE 4164–01–P
the information at: http://www.fda.gov/
regulatoryinformation/dockets/ II. Significance of Guidance
default.htm. This guidance is being issued DEPARTMENT OF HEALTH AND
consistent with FDA’s good guidance HUMAN SERVICES
Docket: For access to the docket to
read background documents or the practices regulation (21 CFR 10.115). Food and Drug Administration
electronic and written/paper comments The guidance represents the current
thinking of FDA on premarket [Docket No. FDA–2016–N–0001]
received, go to http://
www.regulations.gov and insert the notification (510(k)) submissions for
electrosurgical devices for general Request for Nominations on the
docket number, found in brackets in the Tobacco Products Scientific Advisory
heading of this document, into the surgery. It does not establish any rights
for any person and is not binding on Committee
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets FDA or the public. You can use an AGENCY: Food and Drug Administration,
Management, 5630 Fishers Lane, Rm. alternative approach if it satisfies the HHS.
1061, Rockville, MD 20852. requirements of the applicable statutes ACTION: Notice.
and regulations.
An electronic copy of the guidance SUMMARY: The Food and Drug
document is available for download III. Electronic Access Administration (FDA) is requesting that
from the Internet. See the Persons interested in obtaining a copy any industry organizations interested in
SUPPLEMENTARY INFORMATION section for of the guidance may do so by participating in the selection of a
information on electronic access to the downloading an electronic copy from nonvoting member to represent the
guidance. Submit written requests for a the Internet. A search capability for all interests of tobacco growers to serve on
single hard copy of the guidance Center for Devices and Radiological the Tobacco Products Scientific
document entitled ‘‘Premarket Health guidance documents is available Advisory Committee for the Center for
Notification (510(k)) Submissions for at http://www.fda.gov/MedicalDevices/ Tobacco Products (CTP), notify FDA in
Electrosurgical Devices for General DeviceRegulationandGuidance/ writing. FDA is also requesting
Surgery’’ to the Office of the Center GuidanceDocuments/default.htm. nominations for a nonvoting member to
Director, Guidance and Policy Guidance documents are also available represent the interests of tobacco
sradovich on DSK3GMQ082PROD with NOTICES
Development, Center for Devices and at http://www.regulations.gov. Persons growers to serve on the Tobacco
Radiological Health, Food and Drug unable to download an electronic copy Products Scientific Advisory
Administration, 10903 New Hampshire of ‘‘Premarket Notification (510(k)) Committee, and an alternate to this
Ave., Bldg. 66, Rm. 5431, Silver Spring, Submissions for Electrosurgical Devices representative. A nominee may either be
MD 20993–0002. Send one self- for General Surgery’’ may send an email self-nominated or nominated by an
addressed adhesive label to assist that request to CDRH-Guidance@fda.hhs.gov organization to serve as a nonvoting
office in processing your request. to receive an electronic copy of the industry representative. Nominations
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Document Created: 2016-08-13 02:21:45
Document Modified: 2016-08-13 02:21:45
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. | |
| 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. | |
| FR Citation | 81 FR 54100 |
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