# 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.
**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.
**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 § 884.4050(b)(4) (21 CFR 884.4050(b)(4)) (for gynecologic use) and § 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 § 884.4050(b)(4) and § 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 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:
| 21 CFR part or guidance | Topic | OMB control No. |
| --- | --- | --- |
| 807, subpart E | Premarket notification | 0910-0120 |
| “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program” | Q-submissions | 0910-0756 |
Dated: May 23, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.