FDA satisfied with BSD 'warning' response
BSD Medical (Salt Lake City) reported that the FDA has informed it by letter that its written response to the FDA warning letter (Medical Device Daily, March 8, 2007) is adequate. "Implementations of the corrective actions you have developed and implemented appear to be adequate," the FDA replied, noting further "no response to this letter is necessary."
The company said that FDA's concerns had been limited to research conduct at a clinical site, and had nothing to do with the safety, efficacy, quality, design or manufacture of BSD's equipment. The data from this site had not been used to seek FDA approval for any BSD product, nor used by BSD to support the efficacy of BSD systems in patient treatment. Research at the site was not funded by BSD, it said. The site had been closed to treating patients since Aug. 31, 2006.
BSD has submitted a PMA application for the BSD-2000 based on a pivotal study conducted in Europe, and this study was not the subject of the FDA letter.
BSD develops systems that deliver precision radiofrequency and microwave energy into diseased sites of the body.