[Federal Register Volume 81, Number 43 (Friday, March 4, 2016)]
[Notices]
[Pages 11577-11579]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04790]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-0435]
Labeling for Permanent Hysteroscopically-Placed Tubal Implants
Intended for Sterilization, Draft Guidance for Industry and Food and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the availability of the draft guidance entitled ``Labeling for
Permanent Hysteroscopically-Placed Tubal Implants Intended for
Sterilization.'' This draft guidance addresses the inclusion of a boxed
warning and a patient decision checklist in the product labeling for
permanent hysteroscopically-placed tubal implants intended for female
sterilization and as well as the content and format of those materials.
This draft guidance is being issued in response to information provided
to FDA, including in comments made at a 2015 Panel meeting and in
comments submitted to the associated public docket, that women are not
receiving or understanding information relating to the risks and
benefits of this type of device. This draft
[[Page 11578]]
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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by May 3, 2016.
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-2016-D-0435 for ``Labeling for Permanent Hysteroscopically-Placed
Tubal Implants Intended for Sterilization.'' 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.
Submit written requests for a single copies of the guidance 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. See SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Jason Roberts, Division of
Reproductive, Gastro-Renal, and Urological Devices, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. G218, Silver Spring, MD 20993-0002, 240-
402-6400.
SUPPLEMENTARY INFORMATION:
I. Background
Female sterilization is a commonly performed surgical procedure
that permanently prevents a woman from becoming pregnant by occluding
her fallopian tubes. Traditionally, surgery has been performed by
bilateral tubal ligation (BTL) through a laparotomy, a mini-laparotomy,
transvaginal approach or at the time of cesarean delivery, and, more
recently, laparoscopy. During BTL, the fallopian tubes are cut or
physically occluded by using various procedures or medical instruments,
such as electrosurgical coagulation, implantable clips, or rings. On
November 4, 2002, FDA approved the Essure System for Permanent Birth
Control, the first permanent hysteroscopically-placed tubal implant, as
an alternative, non-incisional method of providing female
sterilization. As the number of hysteroscopic sterilizations with such
devices has increased, additional information, including reports of
adverse events, has accumulated. Some of these events have resulted in
surgery and/or removal of the implants.
The Federal Register on July 22, 2015 (80 FR 43440), announced a
meeting of a public advisory committee of the FDA to seek expert
scientific and clinical opinion on the risks and benefits of the Essure
System for Permanent Birth Control. On September 24, 2015, FDA convened
its Obstetrics and Gynecology Devices Panel of the Medical Devices
Advisory Committee to discuss available data regarding benefits, risks,
and potential mitigation strategies to prevent or reduce the frequency/
severity of the adverse events reported in association with this device
(Ref. 1). FDA is issuing this draft guidance document after considering
the input of the Panel members and other stakeholders. FDA believes
that the labeling described in this guidance will help to ensure that
women are receiving and understanding information about the risks and
benefits of these devices so that they can make informed decisions
regarding use of these devices. In addition to issuing this guidance,
FDA continues to determine what, if any, further actions are warranted
in response to these reported adverse events.
[[Page 11579]]
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 ``Labeling for
Permanent Hysteroscopically-Placed Tubal Implants Intended for
Sterilization.'' 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 ``Labeling for Permanent
Hysteroscopically-Placed Tubal Implants Intended for Sterilization''
may send an email request to [email protected] to receive an
electronic copy of the document. Please use the document number 1500051
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 801, regarding labeling have
been approved under OMB control number 0910-0485.
V. Reference
The following reference is on display in the Division of Dockets
Management (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it are also
available electronically at http://www.regulations.gov. FDA has
verified the Web site address, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.
1. Meeting Materials of the Obstetrics and Gynecology Devices Panel
(2015), available at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevices/ucm463457.htm.
Dated: February 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04790 Filed 3-3-16; 8:45 am]
BILLING CODE 4164-01-P