Zdrowie i gospodarka · 04/05/2016

FDA Exempts New Glucose Test System from Premarket Notification Requirements

The FDA is announcing that it has received a petition requesting exemption from the premarket notification requirements for a new glucose test system in a reagent tablet format, which is intended to measure glucose in urine. The system is used to diagnose and treat carbohydrate metabolism disorders, including diabetes, and the FDA is seeking public comments on the petition.