Good news from HealthImaging.com for Health IT device providers, FDA exempts many health IT devices from review;
The FDA has down-classified Medical Device Data Systems, including hardware and software used to display, transfer and store medical device data, making the devices “low-risk” products exempt from pre-market review.
Previously classified as Class III (high-risk) devices, or as accessories to other devices, many health IT devices such as hardware that collects and stores data from a glucose meter or software that transfers lab results, will be considered low-risk, Class I devices, according to the new rule, originally proposed in 2008.
The FDA requires Class I device manufacturers to register their products with the agency, report adverse events and meet the FDA’s Quality Systems regulations, a basic system of manufacturing and design controls intended to ensure pre-market product testing by the company itself. Notably, Class I devices are exempt from premarket notification and review.
“This rule is a common-sense regulatory approach that provides clarity and predictability for manufacturers of these data systems,” said Jeffrey Shuren, MD, director of FDA’s Center for Devices and Radiological Health. “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.”