Regulatory on stability studies for In-vitro diagnostic medical device

Abstract

The stability of an in-vitro diagnostic (IVD) medical device reagent is the ability to maintain the performance characteristics over a defined time interval. The stability studies are performed to demonstrate that the product remains viable under the specified storage condition until the claimed time period. Since, stability of the IVD cannot be directly assessed through accuracy, performance attributes or customer testing; it is the responsibility of the manufacturer to evaluate the performance of the product by identifying critical factors affecting the stability through developing stability plan, stability protocol and conducting real-time stability studies, accelerated stability studies, in-use stability studies and transport simulated stability studies