The warning letter addresses three general areas: monitoring, securing investigator compliance with the protocol and reporting, the company said.
Medical systems developer BSD added that the concerns outlined by the FDA are limited to clinical study conduct and have nothing to do with the safety, efficacy, quality, design or manufacture of the company's equipment. The research site has been closed to treating patients since August 31, 2006.
The Salt Lake City-based company said that it intends to provide the FDA with a complete report of the actions taken in response to the letter.