FDA Issues Draft Guidance on Medical Device Interoperability

On January 26, 2016, the FDA offered for public comment its draft guidance on medical devices and interoperability,  Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices—Draft Guidance for Industry and Food and Drug Administration Staff.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.

Mark Davis
Mark Davis is an associate in our Orange County office. His practice is focused on patent litigation and prosecution. Mr. Davis earned his Bachelor of Science in Mechanical Engineering at Brigham Young University, where he competed in the international University Rover Challenge. After graduation, he worked as a regulatory compliance engineer at Novarad, a small medical device company. Following his work as an engineer, Mr. Davis attended the University of Texas School of Law. At Texas, he was an officer in the Texas IP Law Society and served as an associate editor of the Texas Law Review. He also represented small business owners and nonprofit groups as a member of the Texas Clinical Law Programs. He joined the firm in 2015.
Click here to read full bio
View all posts published by Mark Davis »

Leave a Reply

By using this blog, you agree and understand that no information is being provided in the context of any attorney-client relationship. You further agree and understand that nothing herein is intended to be legal advice. This blog is solely informational in nature, and is not intended as, and should not be used as, a substitute for competent legal advice from a retained and licensed attorney in your state. Knobbe Martens LLP makes no representations or warranties as to the accuracy, completeness, timeliness or availability of the information in this blog. Knobbe Martens LLP will not be liable for any injury or damages relating to your use of, or access to, any such information. Knobbe Martens LLP undertakes no obligation to correct or update information on this blog, which may be incorrect or become incorrect or out of date over time. Knobbe Martens LLP reserves the right to alter or delete content or information on the blog at any time. This blog contains links and references to other websites and publications that you may find of interest. Knobbe Martens LLP does not control, promote, endorse or otherwise have any affiliation with any other websites or publications unless those websites or publications expressly state such an affiliation. Knobbe Martens LLP further has no responsibility for, and makes no representations regarding, the content, accuracy or any other aspect of the information in such websites or publications.