SQA Regulatory Surveillance Summary | Monthly Update 2022 – Spring
SQA
MAY 17, 2022
Requirements for classification and related issues established under RDC 185/2001, as well as other relevant medical device regulations, will apply for SaMD, as well. United States Food and Drug Administration (FDA) – Regulations and Guidances. United States Food and Drug Administration (FDA) – Recalls.
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