510(k) medical software

Deloitte report offers guidance for FDA's upcoming software regulation pathway
By Dave Muoio | 04:40 pm | March 13, 2018
A recently released analysis report from the Deloitte Center for Government Insights that examines the US’s current and proposed software as a medical device (SaMD) regulatory landscape, and includes suggestions on how the FDA’s pre-certification pilot program and other initiatives could better serve this fast-moving industry.