Experts Debate Which Predictive Tools Should Be Considered Medical Devices

(October 11, 2022. Elise Reuter. MedTechDive)

The FDA issued updated recommendations for Industry and FDA staff. This guide includes CDS software functions to better understand what meets the definition of device. This welcomed clarity brings to light predictive tools that are now meet the criteria for device. Now, experts are weighing in on what predictive tools should be considered.

https://www.medtechdive.com/news/fda-regulate-sepsis-software/633732/