The Complizen blog
Notes from the FDA frontier.
153 posts and counting — every CDRH guidance, warning letter, and explainer worth your time.
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Showing 25–27 of 27 · Software, AI & SaMD
Software, AI & SaMD
SaMD
What Counts as SaMD? FDA Definition in Plain English
Learn the FDA’s definition of Software as a Medical Device (SaMD), a 3‑step litmus test, common edge cases, and a free SaMD checker.
Software, AI & SaMD
SaMD
FDA Guide to AI/ML SaMD: Pathways, PCCP, and Evidence
Learn how the FDA regulates Artificial Intelligence and Machine Learning (AI/ML) in Software as a Medical Device (SaMD). Discover challenges, key guidelines, and future regulatory frameworks.
Software, AI & SaMD
SaMD
FDA's Software as a Medical Device (SaMD) Explained
Learn how the FDA regulates Software as a Medical Device (SaMD) and discover tips for navigating the submission process, addressing cybersecurity, usability, and validation challenges.