[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Product Labeling for Laparoscopic Power Morcellators; Draft
Guidance for Industry and Food and Drug Administration Staff;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the availability of the draft guidance entitled ``Product Labeling for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 This draft guidance proposes updated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 This draft guidance is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DATES: Submit either electronic or written comments on the draft
guidance by April 27, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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 [email protected] 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