Zdrowie i gospodarka · 24/10/2017

FDA Classifies Device to Detect Non-Microbial Analytes for Sepsis Assessment

The FDA is classifying a device to detect and measure non-microbial analytes in human clinical specimens to aid in assessing patients with suspected sepsis into Class II, special controls, citing a reasonable assurance of safety and effectiveness, and aiming to reduce regulatory burdens and enhance patient access to innovative devices.