On January 26, 2016, the FDA offered for public comment its draft guidance on medical devices and interoperability, Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices—Draft Guidance for Industry and Food and Drug Administration Staff. The guidance defines interoperability as the interconnectedness of two or more different devices or systems that allow for “the availability and sharing of information . . . even when products from different manufacturers are used.” It specifically does not limit interoperability to “unidirectional patient data” and instead expands that to include “more complex interactions, such as exerting command and control over a medical device.” It suggests this can be accomplished through “use of standardized architectures and communication protocols” and specifying “non-standard interface requirements and characteristics” through public labeling.
The FDA’s intent in offering the guidelines is to encourage interoperability of medical devices and to improve patient care and efficiency while taking into account safety and security. It highlights three major design considerations for medical device manufacturers to consider as an industry: 1) designing systems with interoperability as an objective; 2) conducting appropriate performance testing and risk management activities; and 3) specifying the functional, performance, and interface characteristics in a public manner such as labeling.
While the guidance is still in draft form and would not be legally binding even after it becomes final, industry reception appears mixed. Some industry commentators have praised the guidance for dealing with devices that actually use shared data automatically for medical purposes and find the FDA’s approach encouraging. Others see the guidance as counterproductive because it places another pseudo-regulatory burden on device manufacturers in the form of additional performance testing and risk management activities.
The initial 60-day comment period was extended and comments can be submitted directly to the FDA in written or electronic form before April 27, 2016.
