Product Labeling for Laparoscopic Power Morcellators; Guidance for Industry and Food and Drug Administration Staff; Availability
| Published date | 30 December 2020 |
| Citation | 85 FR 86570 |
| Record Number | 2020-28816 |
| Section | Notices |
| Court | Food And Drug Administration |
Federal Register, Volume 85 Issue 250 (Wednesday, December 30, 2020)
[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 [email protected] 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
