In Brief: SensorMedics
This article was originally published in The Gray Sheet
Executive Summary
SensorMedics: Plans to meet with FDA in September to discuss civil penalty actions pending against the company. The firm intends to argue for waiver of proposed penalties totaling $2 mil. SensorMedics says FDA's charges should be dropped because the nine devices originally cited as violating premarket requirements no longer are on the market, having been replaced by next-generation products. In addition, the firm maintains that modifications it made to its devices were not subject to 510(k) requirements because they did not affect safety and effectiveness. Earlier this year, FDA waived penalties against Lexicor, citing corrective actions the company had taken and the firm's inability to pay the proposed fines ("The Gray Sheet" Aug. 12, p. 6)...