Bradley Merrill Thompson
Bradley Merrill Thompson is a member of the firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues.
August 23, 2017
There seems to be a modern day gold rush as companies explore how to use machine learning in clinical decision support software. Unfortunately for libertarians, FDA will regulate some of that software because of its risk profile. While the 21st Century Cures Act that passed last December exempted certain CDS from regulation and indeed FDA intends to exempt even more, FDA will continue to regulate...