Food and Drug Administration issued final guidance documents that take noticeably lighter regulatory hand when it comes to mobile applications and medical device data systems
The Telecommunications Industry Association (TIA) has submitted comments to the Food and Drug Administration (FDA) in support of its new approach to medical device data systems
(MDDS) devices, medical image storing devices, and medical image communication devices.
On the regulatory side, the FDA in February announced a final rule that classifies certain off-the-shelf or custom hardware and software products used with medical devices as Medical Device Data Systems
(MDDS), or class I low-risk devices, making them exempt from pre-market review, but still subject to quality standards.
Overall, the meeting and expo provide a unique opportunity to address many of the pertinent issues facing the industry, such as alarm fatigue, benchmarking, cyber attacks on medical devices and changes in medical device data systems