Implications of new FDA rule on mobile medical devices still unclear

The U.S. Food and Drug Administration (FDA) long awaited rule regulating how hardware manufacturers can introduce new mobile medical devices for use by health care providers went into effect earlier this month.

It is yet to be seen what will be the impact of the new regulations on medical equipment developers and software vendors as it is too early to predict how it will influence the market.

The new Medical Device Data Systems (MDDS) rule now classifies most health-related IT devices as Class I or low-risk medical devices. The rule requires IT companies to register health care hardware and software that transfer, store, convert or display health care data.

"This rule is a common-sense regulatory approach that provides clarity and predictability for manufacturers of these data systems," Dr. Jeffrey Shuren, who heads the FDA center for review of medical devices M.D. said in a statement. 


"This shows our flexibility in applying regulations for medical device data systems that are not overly burdensome for manufacturers, but continue to assure that data stored, transferred or displayed on these systems remain reliable," said Shuren.