Medical device software regulations to be relaxed, FDA decides

The Food & Drug Administration exempts certain hardware and software products for medical devices from pre-market review.

The Food & Drug Administration loosened regulations for certain hardware and software products for medical devices.

The federal watchdog agency freed medical device data systems from pre-market review, ruling that they’re Class I, essentially “low-risk,” devices.

“This rule is a common-sense regulatory approach that provides clarity and predictability for manufacturers of these data systems,” Dr. Jeffrey Shuren, head of the FDA’s Center for Devices & Radiological Health, said in prepared remarks. “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,” he said.

Before this “down-classifying,” first proposed three years ago, the agency considered MDDS products to be either high-risk Class III devices — requiring the rigorous pre-market approval process — or accessories to existing devices. The new ruling means that IT companies that make the systems and hospitals that develop them can follow Class I requirements as well.

The agency defines MDDS as “off-the-shelf or custom hardware or software products used alone or in combination that display unaltered medical device data, or transfer, store or convert medical device data for future use, in accordance with a preset specification,” including “devices that collect and store data from a glucose meter for future use or that transfer lab results to be displayed at a nursing station for future use.”.