This occasional column provides summaries of newly released FDA guidances of interest to our readers.
Clinical Trials for BPH Devices
A draft guidance released by the FDA last week contains new recommendations for sponsors conducting clinical trials of devices to treat benign prostatic hyperplasia (BPH), including advice for randomization, endpoints, statistical analysis, patient selection and followup.
The provisions in the draft would replace those in the current final guidance on clinical investigations of devices to treat BPH, dated August 2010. Comments on the draft are due by Sept. 14.
Devicemakers submitting premarket applications for high-intensity ultrasound prostate tissue ablation systems must first conduct clinical trials of the systems under a final regulation the FDA released last week.
Prostate tissue ablation devices of this type present significant risk, the guidance says, and sponsors must comply with Investigational Device Exemption regulations, including IRB review. It also gives advice on study design and duration, inclusion/exclusion criteria, protocols, endpoints and data analysis.
