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GUIDANCE DOCUMENT

Clinical Investigations for Prostate Tissue Ablation Devices Guidance for Industry and Food and Drug Administration Staff June 2019

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Clinical Investigations for Prostate Tissue Ablation Devices

Submit Comments by 08/26/2019

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2019-D-2223


Docket Number:
FDA-2019-D-2223
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This draft guidance document, when finalized, will provide recommendations for (1) complying with the clinical testing special control under 21 CFR 876.4340(b)(8) for premarket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).