[Federal Register Volume 85, Number 38 (Wednesday, February 26, 2020)]
[Notices]
[Pages 11093-11094]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03827]


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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Product Labeling for Laparoscopic Power Morcellators; Draft 
Guidance for Industry and Food and Drug Administration Staff; 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the availability of the draft guidance entitled ``Product Labeling for 
Laparoscopic Power Morcellators.'' This draft guidance proposes updated 
``Contraindications'' and ``Warnings'' in product labeling information 
to reflect the state of the science and available technology regarding 
use of laparoscopic power morcellators (LPMs). This draft guidance is 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DATES: Submit either electronic or written comments on the draft 
guidance by April 27, 2020 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-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.
     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.
    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 
``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,'' (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/immediately-effect-guidance-document-product-labeling-laparoscopic-power-morcellators) FDA 
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 when LPMs are used. Parasitic myomas and disseminated 
peritoneal leiomyomatosis, while benign, have been associated with the 
need for additional surgery due to symptoms

[[Page 11094]]

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 proposing in this draft guidance to 
update 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.
    FDA considered comments received on the final guidance document 
that appeared in the Federal Register of November 25, 2014 (79 FR 
70193). FDA revised the guidance as appropriate in response to the 
comments.

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 ``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.

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 ``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 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:

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                                                            OMB control
            21 CFR part                     Topic               No.
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807, subpart E....................  Premarket                  0910-0120
                                     notification.
800, 801, and 809.................  Medical Device             0910-0485
                                     Labeling
                                     Regulations.
803...............................  Medical Devices;           0910-0437
                                     Medical Device
                                     Reporting;
                                     Manufacturer
                                     reporting, importer
                                     reporting, user
                                     facility reporting,
                                     distributor
                                     reporting.
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    Dated: February 20, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-03827 Filed 2-25-20; 8:45 am]
BILLING CODE 4164-01-P


