Use of Safety and Performance to Determine Substantial Equivalence – FDA Issues New Guidance for Medical Devices Oct 7, 2019 | EAS in the News Medical Device, Medical Devices ISPE iSpeak blog October 7, 2019 https://ispe.org/pharmaceutical-engineering/ispeak/use-safety-and-performance-determine-substantial-equivalence-fda Amy Scanlin Posted in EAS in the News Medical Device, Medical Devices.