FDA Recognizes Safety Standard for Interoperable Devices

The FDA has designated a new safety standard for systems that exchange and use information among one or more devices or technologies.

The standard, which provides a set of requirements for ensuring safe, secure interoperability between medical systems, can be used in premarket submissions to demonstrate conformity now that it’s been recognized by the FDA.

It also recommends clinical and engineering properties that are significant components of effective device interoperability.