The US Food and Drug Administration (FDA) on Thursday opened a public consultation on a harmonized guidance on the clinical evaluation of software as a medical device (SaMD) developed by the International Medical Device Regulators Forum (IMDRF).
According to IMDRF, the goal of the guidance is « to establish a common and converged understanding of clinical evaluation and principles for demonstrating the safety, effectiveness and performance of [SaMD]. »
Specifically, the guidance provides recommendations for devicemakers on methods of clinical evaluation and the level of clinical evidence necessary to support the use of a SaMD based on previously finalized IMDRF guidance on risk categorization for SaMD, and lays out when SaMD should undergo an independent review.
« Based on the significant impact SaMD has on clinical outcomes and patient care, a SaMD manufacturer is expected to gather, analyze, and evaluate data, and develop evidence to demonstrate the assurance of safety, effectiveness and performance of the SaMD, » the guidance states.
However, the guidance states that the recommendations made within are « not meant to replace or conflict with premarket or postmarket regulatory requirements related to the regulatory classification of SaMD in different jurisdictions, » and notes that « the recommendation for independent review for certain categories of SaMD does not imply the need for premarket review (authorization) by a regulatory authority. »
To read the article by Michael Mezher