[Federal Register Volume 85, Number 250 (Wednesday, December 30, 2020)]
[Notices]
[Pages 86570-86571]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28816]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1804]


Product Labeling for Laparoscopic Power Morcellators; 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 ``Product Labeling for 
Laparoscopic Power Morcellators.'' This guidance updates recommended 
``Contraindications'' and ``Warnings'' information to be included in 
product labeling to reflect the state of the science and available 
technology regarding use of laparoscopic power morcellators (LPMs). 
These labeling recommendations are intended to enhance, but not 
replace, the physician-patient discussion of the benefits and risks of 
use of LPMs that uniquely pertain to individual patients.

DATES: The announcement of the guidance is published in the Federal 
Register on December 30, 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-2014-D-1804 for ``Product Labeling for Laparoscopic Power 
Morcellators.'' 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 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 
``Product Labeling for Laparoscopic Power Morcellators'' 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: Veronica Price, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2659, Silver Spring, MD 20993-0002, 301-796-6538.

SUPPLEMENTARY INFORMATION:

I. Background

    Following issuance of the 2014 guidance document entitled 
``Immediately in Effect Guidance Document: Product Labeling for 
Laparoscopic Power Morcellators,'' FDA has continued to consider new 
scientific information and the input of stakeholders. Additional 
scientific information is available that stratifies the risks of an 
undetected uterine cancer in women with presumed fibroids based on age.
    FDA also considered scientific information pertaining to the risk 
of spreading benign uterine tissue beyond the uterus during gynecologic 
surgeries

[[Page 86571]]

when LPMs are used. Parasitic myomas and disseminated peritoneal 
leiomyomatosis, while benign, have been associated with the need for 
additional surgery due to symptoms such as abdominal pain and 
distension. Finally, FDA considered additional available mitigations 
for the spread of uterine tissue. Since 2014, FDA has provided 
marketing authorization for LPM containment systems intended to isolate 
and contain tissue that is considered benign. These products have been 
shown, through bench testing and simulated use testing, to contain such 
tissue during morcellation.
    For these reasons, FDA is updating its recommendations, as 
originally described in the 2014 guidance document, concerning the 
content and format of certain labeling information for LPMs. 
Specifically, FDA is recommending that manufacturers incorporate into 
the labeling for these devices information providing greater 
specificity regarding the risks of use as it relates to age, 
information regarding the risk of spreading benign uterine tissue, and 
information regarding the use of LPM containment systems.
    A notice of availability of the draft guidance appeared in the 
Federal Register of February 26, 2020 (85 FR 11093). FDA considered 
comments received and revised the guidance as appropriate in response 
to the comments, including revisions to further discuss shared decision 
making that should occur between a physician and patient prior to 
undergoing the procedure, to elaborate on the benefits and risks of LPM 
containment systems, and to refine one of the sample warning 
statements.
    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 product labeling for laparoscopic power 
morcellators. 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 and at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to 
download an electronic copy of ``Product Labeling for Laparoscopic 
Power Morcellators'' may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. 
Please use the document number 1400052 and complete title to identify 
the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in the following FDA regulations have been approved by 
OMB as listed in the following table:

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                                                            OMB control
          21 CFR part                     Topic                 No.
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807, subpart E.................  Premarket notification.       0910-0120
800, 801, and 809..............  Medical Device Labeling       0910-0485
                                  Regulations.
803............................  Medical Devices;              0910-0437
                                  Medical Device
                                  Reporting;
                                  Manufacturer
                                  reporting, importer
                                  reporting, user
                                  facility reporting,
                                  distributor reporting.
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    Dated: December 22, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-28816 Filed 12-29-20; 8:45 am]
BILLING CODE 4164-01-P


