FDA CDS guidelines

By Bradley Merrill Thompson 01:23 pm April 11, 2018
About the Author: 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. Since the Medical Device Amendments of 1976, a hallmark of FDA’s regulation of medical devices has been the agency’s risk-based approach....