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No, accelerated studies or extrapolated data from real time data are not sufficient for claiming the shelf life of a medical device. As per the Final-stability-guidance-2024 document issued by CDSCO, the stated shelf-life of a medical device must be based on real-time experimental results. Accelerated studies or extrapolated data from real time data are acceptable for initial shelf life claim but need to be followed up with real time stability studies to justify the claimed shelf life.
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