Non-clinical performance assessment of tissue containment systems used during power morcellation procedures: guidance for industry and Food and Drug Administration staff

Non-clinical performance assessment of tissue containment systems used during power morcellation procedures: guidance for industry and Food and Drug Administration staff

Collection:
Health Policy and Services Research
Contributor(s):
Center for Devices and Radiological Health (U.S.), issuing body.
Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, May 26, 2023
Language(s):
English
Format:
Text
Subject(s):
Device Approval
Government Regulation
Morcellation -- instrumentation
Morcellation -- legislation & jurisprudence
Morcellation -- standards
United States
Genre(s):
Guideline
Technical Report
Abstract:
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. These devices are class II (special controls) and subject to premarket notification (510(k)) requirements. Throughout this guidance, the terms “FDA,” “the Agency,” “we,” and “us” refer to the Food and Drug Administration and the terms “you” and “yours” refer to medical device manufacturers. For the current edition of the FDA-recognized consensus standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database. For more information regarding use of consensus standards in regulatory submissions, please refer to the FDA guidance titled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.” In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (17 pages))
NLM Unique ID:
9918662585506676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918662585506676