FDA pilot program for medical device review tool development in the works

FDA pilot program for medical device review tool development in the works-massdevice: A new pilot program planned by the US Food and Drug Administration is being planned to develop tools for more effective and efficient reviews of medical device premarket applications. According to new guidance, the agency will begin seeking participants for its Medical Device Development Tools (MDDT) Pilot Program in September 2014. Qualified MDDT program participants would develop tools for use by both regulators and manufacturers to evaluate performance, safety and effectiveness of devices before and during their US premarket registrations.