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# Prostate Tissue Ablation Device Guidance
- URL: https://www.fdaweb.com/prostate-tissue-ablation-device-guidance/
- Published: 2020-07-14T12:00:00.000Z
- Updated: 2026-09-14T16:21:06.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147188

FDA has published a guidance, *Clinical Investigations for Prostate Tissue Ablation Devices*, with recommendations for complying with the clinical testing special control for 510(k)s for high-intensity ultrasound systems for prostate tissue ablation. The [document](https://www.fda.gov/media/128263/download?ref=fdaweb.com) also makes recommendations for collecting clinical data to support marketing submissions for new types of prostatic tissue ablation devices.

The guidance scope is limited to the clinical investigations to support marketing authorization for general indications of prostate tissue ablation systems, including devices that are regulated under the product code PLP. It does not address the clinical investigations of devices that are intended to treat specific prostatic diseases. It also does not address recommendations or other requirements for non-clinical testing, training, or labeling of prostate tissue ablation systems.