New Connected-Health Standards Signal US FDA's Future Thinking

Standards organizations say software and informatics standards recently recognized by US FDA are a sign of the technologies the agency expects to tackle in future product applications and a signal to industry about priorities.

US FDA newly recognized multiple software and informatics standards this summer, including seven dealing with "personal health device communication" for different types of equipment. The move signals an expectation by the agency that it is going to receive an uptick in submission in this area, stakeholders say.

The notice issued by the agency in August recognized standards (contain in versions of the ISO/IEEE 11073 standard)...

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