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.
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Germany’s electronic patient record – ePA – is a flagship initiative of the ongoing national healthcare reform. The medtech industry welcomes rollout of the ePA while calling for further improvements.
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
EirMed CEO Richard Houlihan warns that EUDAMED (the European database on medical devices) publication delays may harm medical device manufacturers. Currently, only a fraction of the required uploads have occurred, creating potential compliance risks as the mandatory deadline approaches.
