510(k) Guidance Shifts Away Substantial Equivalence in Favor of Performance Testing and Criteria Apr 11, 2019 | EAS in the News Medical Device, Medical Devices MedTech Intelligence April 11, 2019 https://www.medtechintelligence.com/column/510k-guidance-shifts-away-substantial-equivalence-in-favor-of-performance-testing-and-criteria/ Jay Mansour Posted in EAS in the News Medical Device, Medical Devices.