Today FDA released a draft guidance to further clarify how it evaluates interoperable medical devices. As the name of the document states, “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices” intends to offer information related to design of such devices, including security and risk management and verification and validation, along with what should be included 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,” according to an agency release. “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.”
There is a 60-day comment period for the draft guidance.