FDA issues draft guidance for interoperable devices

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The FDA has issued draft guidance to provide clarity on how the agency evaluates medical devices that electronically connect and interact with other devices or systems.

The guidance provides manufacturers with design considerations for developing interoperable medical devices and recommendations on information to include in pre-market submissions and device labeling, according to the agnecy. 

"The FDA believes that the use and development of standards that support interoperability of medical devices is vital to creating interoperable systems that are reliable and safe."