Regulatory News In Brief

BPH guidance: FDA published 1guidance on clinical and non-clinical investigation of devices for treating benign prostatic hyperplasia (BPH) Aug. 17. FDA recommends use of the American Urological Association Symptom Index to measure effectiveness in pivotal trials, but other primary outcome measures could include documented improvement in flow rate, results of pressure/flow studies and post-void residual urine volume, FDA notes. Comments may be submitted at anytime to 2Regulations.gov