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FDA Clinical Investigations for Prostate Tissue Ablation Devices

蒋千琴 12/8/2021 浏览 150 FDA US

标准简介

Clinical Investigations for Prostate Tissue Ablation Devices[附网盘链接]是Food And Drug Administration于过去发布的FDA标准，适用于US。

标准截图

Clinical Investigations for Prostate Tissue Ablation Devices[附网盘链接]
Clinical Investigations for Prostate Tissue Ablation Devices[附网盘链接](截图)

 

标准文档说明

标准文档类型为Clinical Investigations for Prostate Tissue Ablation Devices[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。

标准部分原文

Clinical Investigations for Prostate Tissue Ablation Devices Guidance for Industry and Food and Drug Administration Staff This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. 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. To discuss an alternative approach, contact the FDA staff or Office responsible for this guidance as listed on the title page. I. Introduction This guidance document provides recommendations for (1) complying with the clinical testing special control under 21 CFR 876.4340(b)(8) for premarket notifications (510(k)s) for high intensity ultrasound systems for prostate tissue ablation, and (2) collecting clinical data to support marketing submissions for new types of prostatic tissue ablation devices. High intensity ultrasound systems for prostate tissue ablation transmit high intensity therapeutic ultrasound energy into the prostate to thermally ablate a defined, targeted volume of tissue. Other prostate ablation devices achieve the same clinical effect of ablating targeted tissue volumes using different sources of energy. Regardless of the energy type used for ablation, these devices may receive marketing authorization for a general indication for ablation of prostatic tissue. This guidance does not address intended uses for the treatment of a specific disease (e.g., prostate cancer or benign prostatic hyperplasia). FDA’s guidance documents, including this guidance, 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 guidance means that something is suggested or recommended, but not required. II. Background In 2015, the Agency granted a De Novo request for a high intensity ultrasound system for 1

prostate tissue ablation. The special control under 21 CFR 876.4340(b)(8) includes a requirement for clinical testing to document the adverse event profile, provide evidence of 1

The DEN150011 transparency summary and final classification order are available at https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN150011.pdf and 82 FR 45725.

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