81 FR 11577 - Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization, Draft Guidance for Industry and Food and Drug Administration Staff; Availability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 43 (March 4, 2016)

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization.'' This draft guidance addresses the inclusion of a boxed warning and a patient decision checklist in the product labeling for permanent hysteroscopically-placed tubal implants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 This draft guidance is being issued in response to information provided to FDA, including in comments made at a 2015 Panel meeting and in comments submitted to the associated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 This draft guidance is not final nor is it in effect at this time.

[Federal Register Volume 81, Number 43 (Friday, March 4, 2016)]
[Notices]
[Pages 11577-11579]
From the Federal Register Online  [www.thefederalregister.org]
[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Intended for Sterilization, Draft Guidance for Industry and Food and 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the availability of the draft guidance entitled ``Labeling for 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 This draft guidance addresses the inclusion of a boxed 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This draft guidance is being issued in response to information provided 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