A couple of years ago, FDA reclassified Medical Device Data Systems from a Class III product requiring premarket approval, to a Class I, 510(k) exempt product. Now the agency says that it doesn’t intend to enforce even the general controls applicable to Class I products.
In a guidance document issued today, FDA said that it has “gained additional experience with these types of technologies, and has determined that these devices pose a low risk to the public health.” Specifically, the agency said that it does not intend to enforce compliance with regulatory controls, including “registration and listing, premarket review, postmarket reporting and quality system regulation.”
This guidance specifically applies to entities other than the original medical device manufacturer, such as hospitals, who write custom software to directly connect to a medical device to obtain medical device data, or who modify hardware or software of an IT infrastructure to add medical device data system functionality.
A medical device data system is intended to transfer, store, display or convert the format of medical device data without modifying data or controlling functions or parameters of any medical device.