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Documenting AI-Enabled SaMD: What FDA’s Jan 2025 Draft Expects
FDA’s Jan 7, 2025 draft for AI-enabled device software functions recommends including: model description, dataset lineage/partitions...
Jun 3, 20253 min read
FDA SaMD Cybersecurity (2025): §524B, SBOM, Testing & eSTAR
In June 2025 FDA finalized its cybersecurity guidance and clarified §524B obligations for “ cyber devices .” For SaMD that connects to...
May 29, 20253 min read
IEC 62304 + ISO 14971 for SaMD: How to Integrate Lifecycle & Risk
Integrate IEC 62304 (software lifecycle) with ISO 14971 (risk management) by mapping hazards → requirements → design → tests →...
May 27, 20253 min read
FDA SaMD Pre-Submission (Q-Sub): When to Request & What to Include
Use an FDA Pre-Submission (Q-Sub) when your SaMD has novel tech/claims , unclear classification/pathway , clinical evidence questions,...
May 22, 20254 min read
FDA eSTAR for SaMD: What Changes After Oct 1 2025?
Starting October 1, 2025 , all De Novo requests for SaMD must be submitted using the FDA’s eSTAR template . This shift brings new module...
May 20, 20253 min read
Which FDA Pathway for SaMD? 510(k), De Novo, or PMA (2025)
Choosing a SaMD pathway depends on risk, novelty, and predicates . Use 510(k) when a suitable predicate exists for the same intended use...
May 15, 20253 min read
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