In final guidance published on September 6, the U. S. Food and Drug Administration (FDA) provided manufacturers with recommendations for ensuring interoperable medical devices are safely and securely designed and developed through a recently published final guidance. The guidance also provides recommendations for labeling an interoperable device and clarity regarding the type of content manufacturers should include in a pre-market submission.
“Interoperability” refers to the ability of two or more products, technologies, or systems to interconnect and use exchanged information such as by displaying, storing, interpreting, or analyzing the shared information. The guidance suggests that the keys to assuring the safety and effectiveness of interoperable medical devices are: (i) designing systems with interoperability as an objective; (ii) conducting verification, validation and risk management; and (iii) specifying the relevant functional, performance, and interface characteristics in a user-friendly manner through labeling.
Manufacturers are advised that when they design and develop devices, they should carefully consider the needs of the anticipated users of the electronic interface (for example, IT personnel or clinician) and the specific purpose of the interoperability. The FDA also recommends that as part of the development process, manufacturers anticipate and address the complex risks associated with interconnectivity in a system of multiple medical devices.
In developing interoperable medical devices, manufacturers should also consider prior FDA guidance aimed at safeguarding against breaches, such as the cybersecurity guidance for medical devices published in December 2016 (discussed here) .