FDA Finalizes Regulation Regarding Software for Medical Devices

Did You Know?

The path to market for software that is to be used with medical devices can be rigorous. The FDA recently announced (Feb. 14, 2011) a "less burdensome path to market" according to FDA News.1 These systems (i.e, software and hardware combined) are known as Medical Device Data Systems (MDDS) and have been recently defined as low-risk devices or "Class I" devices, which definition relieves medical device professionals of the immense effort required during premarket review. However the MDDS systems will of course still be "subject to quality standards."2

Quoted in FDA News, Dr. Jeffrey Shuren states: "This rule is a common-sense regulatory approach that provides clarity and predictability for manufacturers of these data systems."3


1-3. FDA Finalizes Regulation for Medical Device Hardware, Software