The FDA has issued draft guidance to provide clarity on how the agency evaluates medical devices that electronically connect and interact with other devices or systems.
The guidance provides manufacturers with design considerations for developing interoperable medical devices and recommendations on information to include in pre-market submissions and device labeling, according to the agnecy.
"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."
Editor
Editor Beth earned a bachelor’s degree in journalism and master’s in health communication. She has worked in hospital, academic and publishing settings over the past 20 years. Beth joined TriMed in 2005, as editor of CMIO and Clinical Innovation + Technology. When not covering all things related to health IT, she spends time with her husband and three children.