Proposed rule on device data systems

Manufacturers of medical device data systems (MDDS) would no longer need to submit PMAs to FDA under a proposed federal rule, but they would become subject to the Quality System Regulation. The draft regulation, issued Feb. 8 by FDA, would change the classification for an MDDS - a device that sends data electronically to another medical device or an electronic health record - from Class III to Class I. A Class III device is typically a high-risk, life-sustaining product, while the Class I designation is for devices that present minimal chance of harm to the patient. FDA states in the proposed rule that the application of the QSR, "particularly the design control provisions, would significantly reduce the risk of errors from these devices.