The US FDA classifies Software as a Medical Device (SaMD) using a risk-based framework. It places software into four classes (I–IV). Class IV represents the highest risk (life-critical decisions). On the other hand, Class I represents the lowest (supportive,...
FDA requires SaMD registration to ensure that standalone medical-purpose software is safe, effective, and legally marketable in the United States. Registration is not just a formality. It establishes credibility, aligns product claims with regulatory expectations, and...
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