Document ID: FDA-2016-D-0435-1366
Agency: fda
Document Type: Notice
Title: Labeling for Permanent Hysteroscopically Placed Tubal Implants 
Intended for Sterilization; Guidance for Industry and Food and Drug 
Administration Staff; Availability
Posted Date: 2016-10-31T04:00Z

[Federal Register Volume 81, Number 210 (Monday, October 31, 2016)]
[Notices]
[Pages 75419-75421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26243]

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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; 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 ``Labeling for Permanent 
Hysteroscopically-Placed Tubal Implants Intended for Sterilization.'' 
This guidance addresses the inclusion of a boxed warning and patient 
decision checklist in the product labeling for permanent 
hysteroscopically placed tubal implants intended for female 
sterilization, and the content and format of those materials. FDA 
believes that the labeling described in this guidance will help to 
ensure that a woman receives and understands information regarding the 
benefits and risks of this type of device prior to undergoing 
implantation. FDA considered comments received on the draft guidance 
and revised the guidance as appropriate.
    The guidance identifies the content and format of certain labeling 
components for permanent, hysteroscopically placed tubal implants that 
are intended for sterilization. The guidance applies to all devices of 
this type, regardless of the insert material composition, location of 
intended implantation, or exact method of delivery.

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-2016-D-0435 for ``Labeling for Permanent Hysteroscopically-Placed 
Tubal Implants Intended for Sterilization, 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 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

[[Page 75420]]

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 
``Labeling for Permanent Hysteroscopically-Placed Tubal Implants 
Intended for Sterilization, Guidance for Industry and Food and Drug 
Administration Staff'' 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: 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, such surgery has been performed by 
surgical bilateral tubal ligation (BTL) through a laparotomy, a mini-
laparotomy, a transvaginal approach or at the time of cesarean 
delivery, and, more recently, laparoscopy. During surgical BTL, the 
fallopian tubes are cut or physically occluded by using various 
procedures or medical instruments, such as electrosurgical coagulation 
or 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.
    In the Federal Register on July 22, 2015 (80 FR 43440), FDA 
announced a meeting of a public advisory committee 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).
    A draft guidance regarding the labeling for permanent 
hysteroscopically placed tubal implants intended for sterilization was 
announced in the Federal Register on March 4, 2016 (81 FR 11577) and 
made available for public comment. The comment period closed on May 3, 
2016. FDA reviewed and considered all public comments received and 
revised the guidance as appropriate, including revisions to the content 
and format of a boxed warning and patient decision checklist. FDA 
intends to require such labeling as part of a premarket approval 
application (PMA) for hysteroscopically placed tubal implants intended 
for sterilization (or a PMA supplement for an already marketed device).

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 ``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 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 CDRH-Guidance@fda.hhs.gov 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 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. References

    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 is 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.

[[Page 75421]]

    Dated: October 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26243 Filed 10-28-16; 8:45 am]
 BILLING CODE 4164-01-P