What regulatory obstacles does SaMD encounter, and how is its certification handled by organizations such as the FDA?
SaMD is confronted with numerous regulatory obstacles, such as those related to data security, validation, and classification. SaMDs must undergo stringent validation to prove their safety and efficacy, and the FDA divides them into risk-based classes (Class I, II, III, and IV).
Software updates make oversight more difficult and necessitate continuous monitoring and post-market surveillance,...
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