The Continua Health Alliance, a consortium of more than 220 organizations working to enable interoperability between personal medical devices, noted in a recent newsletter that the FDA believes new laws for connected health device regulations are neither likely nor needed. The revelation came after Continua hosted a pow-wow with industry folks at FDA head quarters last month — MobiHealthNews stopped by, too.
“Among the workshop conclusions was consensus that regulation of interoperable medical devices is different than stand-alone medical devices, but new laws are neither likely nor needed. FDA believes that existing tools are flexible enough to address the safety and effectiveness concerns raised by these issues. The FDA wants to partner with industry (manufacturers and providers) and users to work out an appropriate regulatory pathway,” Continua noted in its newsletter.
“The path forward includes the development of standards, guidance documents, and a robust risk/regulatory model for integrated ’systems of systems.’ A ‘prototype’ regulatory pathway needs to be explored to allow FDA, manufacturers and other interoperability stakeholders to identify and address issues in the process for regulatory approval,” the Alliance wrote.