Zdrowie i gospodarka · 26/02/2015

FDA Classifies Assisted Reproduction Embryo Image Assessment System into Class II (Special Controls)

The FDA is classifying the Assisted Reproduction Embryo Image Assessment System into class II (special controls) to ensure the device provides a reasonable assurance of safety and effectiveness. This classification will apply special controls to the device, which will be part of the codified language for the Assisted Reproduction Embryo Image Assessment System classification.