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Lasers for BPH

This article was originally published in The Gray Sheet

Executive Summary

FDA reiterates policy that lasers cannot be promoted for treatment of benign prostatic hypertrophy without agency clearance ("The Gray Sheet" Nov. 9, I&W-10) in a Jan. 14 letter to the American Urological Association. To date, no manufacturers have obtained clearance for BPH. In order to gain BPH clearance, manufacturers must conduct clinical trials under an investigational device exemption, FDA says. The agency tells AUA that it will not restrict individual practitioners' use of the devices for BPH; however, FDA emphasizes that its policy to not interfere with physicians' practice "should not be construed as an endorsement of [the BPH] procedure by FDA. Our position is that there are insufficient data at this point to establish the safety and effectiveness of lasers for this specific purpose"....
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