Document ID: FDA-2016-D-3275-0007
Agency: fda
Document Type: Notice
Title: Product Labeling for Certain Ultrasonic Surgical Aspirator Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
Posted Date: 2017-10-30T04:00Z

[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)]
[Notices]
[Pages 50138-50139]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23520]

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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; 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 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 fibroids.

DATES: The announcement of the guidance is published in the Federal 
Register on October 30, 2017.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to Dockets Management 
Staff, 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-2016-D-3275 for ``Product Labeling for Certain Ultrasonic Surgical 
Aspirator Devices; Guidance for Industry and Food and Drug 
Administration Staff.'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at Dockets 
Management Staff 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 https://www.regulations.gov. 
Submit both copies to Dockets Management Staff. 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: 
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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 
``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-

[[Page 50139]]

addressed adhesive label to assist that office in processing your 
request.

FOR FURTHER INFORMATION CONTACT: Trisha Eustaquio, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1529, Silver Spring, MD 20993-0002, 301-
796-5214.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is issuing this guidance to recommend the addition of a 
specific safety statement to the product labeling of certain ultrasonic 
surgical aspirator devices. This guidance applies to ultrasonic 
surgical aspirator devices with indications for use in laparoscopic 
surgery, open surgery, or gynecologic surgery, as such surgeries can 
include gynecologic procedures. 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 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 indications for use in laparoscopic surgery, 
open surgery, 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 fragmentation, 
emulsification, and aspiration of uterine fibroids.
    In the Federal Register on November 10, 2016 (81 FR 79028), FDA 
announced the availability of the draft guidance and interested parties 
were invited to comment by January 9, 2017. FDA has considered all of 
the public comments received prior to finalizing this guidance.

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 ``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. This guidance is not subject to Executive 
Order 12866.

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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at https://www.regulations.gov. Persons 
unable to download an electronic copy of ``Product Labeling for Certain 
Ultrasonic Surgical Aspirator Devices; Guidance for Industry and Food 
and Drug Administration Staff'' 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 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 and the collections of 
information in 21 CFR part 801 have been approved under OMB control 
number 0910-0485.

    Dated: October 25, 2017.
Lauren Silvis,
Chief of Staff.
[FR Doc. 2017-23520 Filed 10-27-17; 8:45 am]
BILLING CODE 4164-01-P