Today, the FDA issued draft guidance: Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices to provide clarity on how the agency evaluates medical devices that electronically connect and interact with other devices or systems. This guidance provides manufacturers with design considerations for developing interoperable medical devices and recommendations on information to include in pre-market submissions and device labeling.
Interoperability refers to the ability of medical devices to interact with other medical devices and systems, including electronic health record systems, and to communicate with each other using a common vocabulary. Connecting interoperable medical devices can improve the efficiency of health care through means such as automatically populating an electronic health record or allowing doctors to monitor their patients remotely to make treatment decisions without physically being in the hospital.
The FDA believes that the use and development of standards that support interoperability of medical devices is vital to creating interoperable systems that are reliable and safe.
We welcome your comments and suggestions regarding this draft guidance. Submit comments to www.regulations.gov, using the docket number FDA-2016-01471.
Food and Drug Administration
Center for Devices and Radiological Health