[Federal Register Volume 81, Number 218 (Thursday, November 10, 2016)]
[Notices]
[Pages 79028-79030]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27106]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-3275]
Product Labeling for Certain Ultrasonic Surgical Aspirator
Devices; Draft Guidance for Industry and Food and Drug Administration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the availability of the draft guidance entitled ``Product Labeling for
Certain Ultrasonic Surgical Aspirator Devices.'' FDA is providing a
specific labeling recommendation in this guidance to promote the safe
and effective use of ultrasonic surgical aspirator devices. The
labeling recommendation is being made in light of the risk of tissue
dissemination and relates to use of these devices in the removal of
uterine fibroid. This draft guidance is not final nor is it in effect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 of 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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by January 9, 2017.
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,
[[Page 79029]]
marked and identified, as confidential, if submitted as detailed in
``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2016-D-3275 for ``Product Labeling for Certain Ultrasonic Surgical
Aspirator Devices.'' 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 draft guidance document entitled
``Product Labeling for Certain Ultrasonic Surgical Aspirator Devices''
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 is issuing a draft guidance to recommend the addition of a
specific safety statement to the product labeling of certain ultrasonic
surgical aspirator devices. This draft guidance applies to ultrasonic
surgical aspirator devices intended for use in general surgery,
laparoscopy, and/or gynecologic surgery. Ultrasonic surgical aspirator
devices are surgical tools intended to fragment, emulsify, and aspirate
hard and soft tissue. However, the mechanism of action of ultrasonic
surgical aspirator devices creates the potential for tissue
dissemination. In light of this risk, FDA is providing a specific
labeling recommendation in this draft guidance regarding use of these
devices in the removal of uterine fibroids.
FDA is aware that ultrasonic surgical aspirator devices are
sometimes used to treat advanced malignancy through cytoreduction (also
known as debulking). When used in advanced cancers, the risk of adverse
clinical effects from tissue dissemination may be small compared to the
device's potential benefits.
In certain clinical circumstances, however, the unintended
dissemination of cancerous cells may have a significant adverse effect
that outweighs any demonstrated benefits. Specifically, use of an
ultrasonic surgical aspirator device during treatment for symptomatic
uterine fibroids on a woman with an occult uterine sarcoma could result
in dissemination of this cancer. Therefore, FDA recommends that
manufacturers of ultrasonic surgical aspirator devices with a general
indication for use in general surgery, laparoscopy, and/or gynecologic
surgery prominently include a specific contraindication in their
product labeling that the device is not indicated for and should not be
used for the removal of uterine fibroids.
FDA is seeking comment on specifically how these devices are used
in practice and whether the proposed contraindication appropriately
limits the patient population when considering the clinical utility of
ultrasonic surgical aspirator devices.
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 current thinking of FDA on Product
Labeling for Certain Ultrasonic Surgical Aspirator Devices. 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 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 ``Product Labeling for Certain
Ultrasonic Surgical Aspirator Devices'' may send an email request to
[email protected] to receive an electronic copy of the
document. Please use the document number 1500072 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 part 801
have been approved under OMB control number 0910-0485.
[[Page 79030]]
Dated: November 4, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-27106 Filed 11-9-16; 8:45 am]
BILLING CODE 4164-01-P