Notice2023-11260
Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures; Guidance for Industry and Food and Drug Administration Staff; Availability
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Published
May 26, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures." This guidance document provides recommendations that may help manufacturers comply with the special controls related to non-clinical performance data for gynecologic and general laparoscopic power morcellation containment systems ("tissue containment systems"). Tissue containment systems are used to enable isolation and containment of tissue during a power morcellation procedure performed following a laparoscopic procedure for the excision of benign tissue that is not suspected to contain malignancy.
Full Text
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<title>Federal Register, Volume 88 Issue 102 (Friday, May 26, 2023)</title>
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[Federal Register Volume 88, Number 102 (Friday, May 26, 2023)]
[Notices]
[Pages 34161-34163]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-11260]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-0737]
Non-Clinical Performance Assessment of Tissue Containment Systems
Used During Power Morcellation Procedures; 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 ``Non-Clinical
Performance Assessment of Tissue Containment Systems Used During Power
Morcellation Procedures.'' This guidance document provides
recommendations that may help manufacturers comply with the special
controls related to non-clinical performance data for gynecologic and
general laparoscopic power morcellation containment systems (``tissue
containment systems''). Tissue containment systems are used to enable
isolation and containment of tissue during a power morcellation
procedure performed following a laparoscopic procedure for the excision
of benign tissue that is not suspected to contain malignancy.
[[Page 34162]]
DATES: The announcement of the guidance is published in the Federal
Register on May 26, 2023.
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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2022-D-0737 for ``Non-Clinical Performance Assessment of Tissue
Containment Systems Used During Power Morcellation Procedures.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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
``Non-Clinical Performance Assessment of Tissue Containment Systems
Used During Power Morcellation Procedures'' to the Office of Policy,
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: Prasanna Hariharan, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 62, Rm. 2222, Silver Spring, MD 20993-0002, 301-
796-2689 or by email at <a href="/cdn-cgi/l/email-protection#d1a1a3b0a2b0bfbfb0ffb9b0a3b8b9b0a3b0bf91b7b5b0ffb9b9a2ffb6bea7"><span class="__cf_email__" data-cfemail="4c3c3e2d3f2d22222d62242d3e25242d3e2d220c2a282d6224243f622b233a">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
This guidance document provides recommendations that may help
manufacturers comply with the special controls related to non-clinical
performance data for gynecologic and general laparoscopic power
morcellation containment systems (``tissue containment systems'').
Tissue containment systems are used to enable isolation and containment
of tissue during a power morcellation procedure performed following a
laparoscopic procedure for the excision of benign tissue that is not
suspected to contain malignancy. This guidance recommends non-clinical
test methods that may help manufacturers meet the non-clinical
performance data requirements identified in the special controls
codified in Sec. 884.4050(b)(4) (21 CFR 884.4050(b)(4)) (for
gynecologic use) and Sec. 878.4825(b)(4) (21 CFR 878.4825(b)(4)) (for
general use), and also includes other non-clinical testing
recommendations to support a 510(k) submission/substantial equivalence
determination. The recommendations in this guidance are based on FDA's
experience evaluating the safety and effectiveness of tissue
containment systems. However, manufacturers may use alternative
approaches and provide different documentation so long as their
approach and documentation satisfy premarket submission requirements in
applicable statutory provisions and regulations.
A notice of availability of the draft guidance appeared in the
Federal Register of June 21, 2022 (87 FR 36859). FDA considered
comments received and revised the guidance as appropriate in response
to the comments, including a clarification that material permeability
testing is recommended to aid in demonstrating substantial equivalence
but is not required in the special controls in Sec. 884.4050(b)(4) and
Sec. 878.4825(b)(4); specifying that aged samples may be subject to
accelerated or real time aging; and indicating that a manufacturer
conducting final finished testing of a tissue containment system with
multiple device sizes may use the worst-case size sample(s), but, if
doing so, should provide a justification for the
[[Page 34163]]
choice of worst-case size sample(s) in its submission.
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 ``Non-Clinical Performance Assessment of
Tissue Containment Systems Used During Power Morcellation Procedures.''
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 <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>. This guidance document is also
available at <a href="https://www.regulations.gov">https://www.regulations.gov</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>. Persons unable to
download an electronic copy of ``Non-Clinical Performance Assessment of
Tissue Containment Systems Used During Power Morcellation Procedures''
may send an email request to <a href="/cdn-cgi/l/email-protection#afecebfde782e8dac6cbcec1cccaefc9cbce81c7c7dc81c8c0d9"><span class="__cf_email__" data-cfemail="f1b2b5a3b9dcb6849895909f9294b1979590df999982df969e87">[email protected]</span></a> to receive an
electronic copy of the document. Please use the document number
GUI00019015 and complete title to identify the guidance you are
requesting.
III. Paperwork Reduction Act of 1995
While this guidance contains no new 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, guidance, and forms
have been approved by OMB as listed in the following table:
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21 CFR part or guidance Topic OMB control No.
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807, subpart E.................. Premarket 0910-0120
notification.
``Requests for Feedback and Q-submissions...... 0910-0756
Meetings for Medical Device
Submissions: The Q-Submission
Program''.
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Dated: May 23, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-11260 Filed 5-25-23; 8:45 am]
BILLING CODE 4164-01-P
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