NOTE: This is for historical reference as a final guidance was issued Sept 2017 and is posted separately.

FDA issued a new draft guidance entitled “Design Considerations and Pre- market Submission Recommendations for Interoperable Medical Devices”. This guidance addresses medical devices that exchange information whether wired or wireless including through the internet. It includes unidirectional exchange, bidirectional, or command and control. The guidance focuses on data exchange not physical connection types. It includes a section on information on interoperability to be included in premarket submissions.

Lines 275-297 identify 5 key considerations under 21 CFR 820.

Lines 314-341 identify key design considerations.

Lines 355-368 identify types of anticipated users to consider.

Lines 396-419 provide examples of security and risk management considerations

Lines 445-458 provide examples of V&V considerations.

Section VI of the guidance defines information to be included in premarket submissions and includes describing the API (Application Programming Interface) if the software can be used by other software, medical device or system.

Lines 669 – 676 discuss interfaces intended only for use by the manufacturer’s technicians.