The FDA issued the final 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, or 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.
Section V identifies six key considerations under 21 CFR 820. Key design considerations identified include:
- purpose of the electronic interface
- anticipated users
- risk management
- use of consensus standards
Section VI of the guidance defines information to be included in premarket submissions, including a description of the API (Application Programming Interface) if the software can be used by other software, medical devices, or systems.
Take a look at the guidance here: Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices