Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Inside Health Policy’s FDA Week, in “FDA: MDDS Software Will Be Exempted from Class I Regulatory Controls,” by David Hood.
Following is an excerpt:
Industry attorney Bradley Merrill Thompson at Epstein Becker & Green said the implications are profound both for MDDS and for the future of health information technology in general.
“FDA is quite earnestly working to ensure that it uses the lightest regulatory touch appropriate for software,” said Thompson, in an email. “It’s exciting, because it means that innovation in this space can truly flourish. This is a very natural extension from the recent FDA guidance on accessories where FDA acknowledges that the risk associated with an accessory is not necessarily the same as the risk of the parent medical device.” …
Still, Thompson said, FDA’s shift from regulating MDDS as device accessories to none at all is remarkable. “FDA is certainly sticking to its word, working to down classify or altogether exempt low-risk software-based technologies.”