Dr. Harvey Arbit of Arbit Consulting has penned a whitepaper for IMARC Research titled, “Significant Risk/Non-Significant Risk Determination and IDE Applicability.”  Although the Medical Device Amendments were enacted on May 28, 1976, it still seems that after all these years there is confusion and misunderstanding regarding the process for determining if an investigational device is Significant Risk (SR) or Non-Significant Risk (NSR).