The US Food and Drugs Administration (FDA) has published finalised guidance on interoperable medical devices. This guidance is intended to be used by manufacturers and FDA staff to identify considerations related to the ability of electronic medical devices to exchange and use information safely and effectively with other medical devices and information systems.
The guidance highlights items that manufacturers should consider how to provide a reasonable assurance of safety and performance of their interoperable devices, such as:
- Including interoperability as a design objective
- Conducting appropriate verification, validation and risk management activities
- Providing the user with the appropriate functional, performance and interface characteristics in the labelling.
The guidance also outlines which information should be included in premarket submission for such devices.
FDA acknowledges that they and industry may need time to implement recommendations listed in the guidance. The agency does not intend to request interoperability information as per the guidance for dossiers submitted for review until 6 November 2017, if such information is not included.
The full guidance document is available on here.