FDA Issues Draft Guidance Regarding Interoperable Medical Devices

On January 26, 2016, FDA-CDRH+CBER published a draft guidance document, UCM482649, entitled Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices. The draft guidance document recognizes that electronic medical devices increasingly connected to other devices and to other technologies. It defines interoperability as the ability of two or more products, technologies, and systems to both exchange information and to use the information exchanged.

The guidance document has a section on Design Considerations for Interoperable Devices and a section with Recommendations for the Contents of Pre-market Submissions.