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UROLOGICAL LASER MANUFACTURERS CAN ADD BPH INDICATION VIA 510(K), FDA SAYS; PROTOCOLS FOR CLEARED DEVICES WITH PROSTATIC INDICATIONS DUE WITHIN 90 DAYS

This article was originally published in The Gray Sheet

Executive Summary

Premarket notification applications for medical lasers for the treatment of benign prostatic hyperplasia (BPH) require "limited confirmatory data" from clinical studies involving a minimum of 50 patients in both treatment and control groups and "using a matched cohort or randomized study design," FDA says in a draft guidance on study requirements needed to support 510(k)s for general use lasers with indications for prostatectomy and the treatment of BPH.
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