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SQA Regulatory Surveillance Summary | Monthly Update 2022 – July/August

SQA

Sections include Terms and Definitions, ML System, ML Approaches, ML Pipeline, and Annex A: Example Data Flow and Date use Statements for Supervised Learning Process. United States Food and Drug Administration (FDA) – Regulations and Guidances. Q3 –When and how should an applicant contact the FDA for feedback on a proposed change?