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 blogOctober 7, 2019https://ispe.org/pharmaceutical-engineering/ispeak/use-safety-and-performance-determine-substantial-equivalence-fdaAmy ScanlinPosted in EAS in the News Medical Device, Medical Devices.