FDA finalized regulations concerning software that accompanies medical devices. PDF Print
FDA: Today, the FDA announced a final rule that provides a less-burdensome path to market for certain hardware and software products used with medical devices. The rule classifies these products, known as Medical Device Data Systems or MDDS, as Class I or low-risk devices, making them exempt from premarket review but still subject to quality standards.

...

 
Share |
Copyright © 2026 Global Dialysis. All Rights Reserved.