FDA: Draft guidance on designing interoperable devices

Editor's Note

The Food and Drug Administration (FDA) on January 26 published draft guidance for “Design considerations and premarket submission recommendations for interoperable medical devices” to assist medical device manufacturers in designing products that are interoperable and can securely share data.

The draft includes factors to consider when developing the electronic data interface, such as the types of technologies to which the device could be connected, data format, transmission or interface standards, and method of data transmission to be used.

Comments will be accepted for 60 days.