[Federal Register Volume 88, Number 102 (Friday, May 26, 2023)]
[Notices]
[Pages 34161-34163]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:
     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-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 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 
``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 [email protected].

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 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, https://www.fda.gov/regulatory-information/search-fda-guidance-documents. 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 [email protected] 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