FDAnews Device Daily Bulletin


April 6, 2006

The FDA has released a summary of the recent meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee.

The panel discussed clinical trial designs for devices intended to treat symptomatic fibroids. The FDA presented the panel with an overview of its regulatory concerns about how to apply the right study design for the varying technologies under development for treatment of fibroids.

In addition, the FDA posed six discussion questions for the panel on appropriate assessment parameters (such as bleeding score, fibroid mass and quality of life measurement), study inclusion/exclusion criteria, study definitions of success, appropriate study control arms, and patient follow-up periods.

Following the presentation, the panel heard eight presentations from device manufacturers and clinical investigators who want to study new fibroid treatment modalities. After that, it provided comments on clinical trial design, addressing elements of study population, outcome measures, controls, and length of follow-up. The FDA will use this input to help guide manufacturers who are developing new devices to treat fibroids.