Posts tagged interoperable medical devices

FDA Guidance Shows a Regulatory Path Forward for Interoperable Devices

Market for interconnected medical devices is projected to grow but the regulatory pathway is still evolving. A new FDA guidance offers helpful recommendations for design and premarket submission.

Regulatory ComplianceNaveen AgarwalApril 2, 2020FDA Guidance, interoperable devices, FDA on interoperable devices, interoperability, medical device innovation, regulatory policy, medical device regulatory policy, premarket guidance, FDA premarket guidance, interoperable medical devicesComment

FDA Unlocks the Key to Innovation in Interoperable Medical Devices

Interoperability holds the key to interconnected medical devices. A recent De Novo classification of a software for diabetes management shows the way forward.

Industry NewsNaveen AgarwalFebruary 25, 2020FDA News, Interoperable medical device, interoperable medical devices, interoperability, interconnected medical devices, De Novo classification, diabetes management, Internet of Medical Things, IoMTComment