FDA TRIAL DATE SET FOR UTAH DEVICE COMPANY

The FDA's suit against Utah Medical Products, which alleges violations of its quality system regulation, is scheduled to begin Sept. 26 in the U.S. District Court for the District of Utah. The agency is seeking an injunction to prevent the company from distributing its products, including devices for the obstetrics, neonatal, gynecology, urology and electrosurgery markets, until these violations are corrected.

The FDA argues that the company failed to validate certain manufacturing processes and computer software, maintain adequate corrective and preventive action procedures, and ensure timely handling of complaints.

The company's lawyers are scheduled to file a pretrial brief on Sept. 19.