FDA will provide a "less burdensome path to market" for certain hardware and software products used with medical devices, Modern Healthcare reports (McKinney, Modern Healthcare, 2/14).
According to a rule published Tuesday in the Federal Register, medical device data systems are products used to convert, display, transfer or store medical device data (Foxhall, Government Health IT, 2/14). According to the rule, such systems now are classified as low-risk Class I devices and will be exempt from premarket review, but still will have to adhere to quality standards. FDA previously classified an MDDS as a Class III device, which required premarket approval (Modern Healthcare, 2/14).
An MDDS does not make adjustments to the data or the data's display, nor does it modify the intended clinical functions of a medical device (Government Health IT, 2/14).