Document ID: FDA-2019-D-4467-1350
Agency: fda
Document Type: Notice
Title: Breast Implants—Certain Labeling Recommendations To Improve Patient Communication; Guidance for Industry and Food and Drug Administration Staff; Availability
Posted Date: 2020-09-29T04:00Z

[Federal Register Volume 85, Number 189 (Tuesday, September 29, 2020)]
[Notices]
[Pages 61001-61003]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21453]

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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; 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 a final guidance entitled ``Breast Implants--
Certain Labeling Recommendations to Improve Patient Communication.'' 
This guidance contains recommendations concerning the content and 
format for certain labeling information for saline and silicone gel-
filled breast implants. FDA is issuing this guidance to help ensure 
that a patient receives and understands the benefits and risks of 
breast implants. These labeling recommendations are intended to 
enhance, but not replace, the physician-patient discussion of the 
benefits and risks of breast implants that uniquely pertain to 
individual patients.

DATES: The announcement of the guidance is published in the Federal 
Register on September 29, 2020.

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 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, 240-402-7500.
     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

[[Page 61002]]

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.govinfo.gov/content/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, 240-402-7500.
    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 
``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: Joseph Nielsen, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4608, Silver Spring, MD 20993-0002, 301-796-6244.

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 (BIA-ALCL) and 
systemic symptoms commonly referred to as breast implant illness (BII) 
that some patients attribute to their implants. FDA has taken a number 
of steps to better understand and address risks associated with breast 
implants, including convening the General and Plastic Surgery Devices 
Advisory Panel on March 25 to 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 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 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. The recommendations in this guidance document supplement the 
recommendations in FDA's guidance entitled ``Saline, Silicone Gel, and 
Alternative Breast Implants.'' \1\
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    \1\ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/saline-silicone-gel-and-alternative-breast-implants.
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    A notice of availability of the draft guidance appeared in the 
Federal Register of October 24, 2019 (84 FR 57028). FDA considered 
comments received and revised the guidance as appropriate in response 
to the comments, including revisions to clarify the labeling 
recommendations regarding the relationship between breast implants and 
systemic symptoms and certain other risks, to refine the 
recommendations regarding information on the patient device card to 
improve clarity and readability, and to provide reference to and 
information regarding ongoing patient registries in the patient 
decision checklist.
    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 ``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.

II. 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/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. 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 and complete title to identify the 
guidance you are requesting.

III. Paperwork Reduction Act of 1995

    This 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:

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 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.

[[Page 61003]]

 
50, 56.........................  Protection of Human           0910-0755
                                  Subjects: Informed
                                  Consent; Institutional
                                  Review Boards.
830............................  Unique Device                 0910-0720
                                  Identification System.
820............................  Quality System                0910-0073
                                  Regulation.
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    Dated: September 24, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-21453 Filed 9-28-20; 8:45 am]
BILLING CODE 4164-01-P