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Category: Medical Device

Categorization and Registration Process for Devices in EUDAMED

Categorization of Devices Categorization of devices to be registered in EUDAMED include: Regulation Devices – Regulation Devices are defined as medical devices and in vitro diagnostic...

Categorization and Registration Process, Categorization of devices to be registered in EUDAMED, eudamed device registration, medical device labeling requirements, Registration Process for Regulation Devices

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Guidance on Premarket Submission for Device Software Functions

The draft guidance is intended to provide information regarding the recommended documentation to include in premarket submissions for the FDA to evaluate the safety and effectiveness of device software...

FDA Medical Device clinical Regulations, fda submission guidance, guidance document pertain to device software functions, Guidance on premarket submission, Medical Device, software design specification medical device, software in a medical device

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