Continua Lauds FDA's Medical Device Interoperability Standards

Reviewing media coverage of the U.S. Food and Drug Administration’s recent announcement that it will recognize standards for medical device interoperability could give a misleading impression that the measure is of little importance. In truth, federal actions to acknowledge interoperability standards in healthcare are among the more sweeping changes we have seen during the time since the Continua Health Alliance was founded in 2006, including activity in the United States, UK, Denmark, Singapore, Japan and the United Arab Emirates.

The FDA’s formal inclusion of these standards on their list of consensus standards helps establish a common framework that adds a measure of predictability for manufacturers that are developing interoperable products. These newly added standards offer approaches and concepts that the FDA recognizes as reasonable to support assessment of product safety. [...]