[Federal Register Volume 84, Number 206 (Thursday, October 24, 2019)]
[Notices]
[Pages 57028-57029]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23197]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-4467]


Breast Implants--Certain Labeling Recommendations To Improve 
Patient Communication; Draft Guidance for Industry and Food and Drug 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the availability of the draft guidance entitled ``Breast Implants--
Certain Labeling Recommendations to Improve Patient Communication.'' 
This draft guidance contains recommendations concerning the content and 
format for certain labeling information for saline and silicone gel-
filled breast implants. FDA is seeking comments on all aspects of the 
draft guidance, including the respective benefits and risks of smooth 
and textured breast implants and applicability of the recommendations 
to both types. This draft guidance is not final nor is it in effect at 
this time.

DATES: Submit either electronic or written comments on the draft 
guidance by December 23, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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 the 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-2019-D-4467 for ``Breast Implants--Certain Labeling Recommendations 
to Improve Patient Communication.'' 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 
the 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 the 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 the 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 draft guidance document entitled 
``Breast Implants--Certain Labeling Recommendations to Improve Patient 
Communication'' to the Office of Policy, 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: Cynthia Chang, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4646, Silver Spring, MD 20993-0002, 301-796-6891.

SUPPLEMENTARY INFORMATION:

I. Background

    Over the past few years, FDA has received new information 
pertaining to risks associated with breast implants, including breast 
implant-associated anaplastic large cell lymphoma and systemic symptoms 
commonly referred to as breast implant illness that some patients 
attribute to their implants. FDA has taken several steps to better 
understand and address risks associated with breast implants, including 
convening the General and Plastic Surgery Devices Panel of the Medical 
Devices Advisory Committee on March

[[Page 57029]]

25-26, 2019, to discuss the long-term benefits and risks of breast 
implants indicated for breast augmentation and reconstruction. FDA 
learned from presentations at the March 2019 panel meeting, and through 
comments submitted to the associated public docket, that some patients 
may not be receiving or understanding important information regarding 
the benefits and risks of breast implants in a format that allows them 
to make a well-informed decision about whether or not to have a breast 
implantation.
    For these reasons, FDA is now providing recommendations concerning 
the content and format of certain labeling information for these 
devices. Specifically, FDA is recommending that manufacturers 
incorporate a boxed warning and a patient decision checklist into the 
labeling for these devices to better ensure certain information is 
received and understood by patients. This draft guidance also 
recommends updated and additional labeling information, including 
updates to the silicone gel-filled breast implant rupture screening 
recommendations, inclusion of an easy-to-find description of materials, 
and provision of patient device cards that were recommended at the 
March 2019 panel meeting.
    This draft guidance is not intended to include a complete listing 
of all labeling components for breast implants. When finalized, the 
recommendations in this draft guidance will supplement or in some cases 
replace recommendations in FDA's guidance entitled ``Saline, Silicone 
Gel, and Alternative Breast Implants'' (November 2006) (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/saline-silicone-gel-and-alternative-breast-implants).
    Based on the information presented at the March 2019 panel meeting, 
FDA continues to gather available information regarding the benefits 
and risks associated with different types of breast implants, and 
consider appropriate labeling and regulatory requirements for them. FDA 
will continue to analyze all available information regarding the risks 
associated with breast implants and take additional actions as 
determined necessary or appropriate. FDA invites comments on the 
benefits and risks of smooth and textured breast implants, 
respectively, as well as the labeling recommendations for these 
implants.

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 ``Breast 
Implants--Certain Labeling Recommendations to Improve Patient 
Communication.'' 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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This 
guidance document is also available at https://www.regulations.gov. 
Persons unable to download an electronic copy of ``Breast Implants--
Certain Labeling Recommendations to Improve Patient Communication'' may 
send an email request to CDRH-Guidance@fda.hhs.gov to receive an 
electronic copy of the document. Please use the document number 19021 
to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information. 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. 3501-3521). The collections of information in 
the following FDA regulations have been approved by OMB as listed in 
the following table:

------------------------------------------------------------------------
 21 CFR Part; guidance; or FDA                             OMB  control
              form                        Topic                 No.
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814, subparts A through E......  Premarket approval.....       0910-0231
812............................  Investigational Device        0910-0078
                                  Exemption.
801............................  Medical Device Labeling       0910-0485
                                  Regulations.
50, 56.........................  Protection of Human           0910-0755
                                  Subjects: Informed
                                  Consent; Institutional
                                  Review Boards.
830............................  Unique Device                 0910-0720
                                  Identification System.
820............................  Current Good                  0910-0073
                                  Manufacturing Practice
                                  (CGMP); Quality System
                                  Regulation.
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    Dated: October 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23197 Filed 10-23-19; 8:45 am]
 BILLING CODE 4164-01-P


