01 · 14 min read
Is Your Software a Medical Device? FDA, EU and India Compared
A practical, source-led framework for deciding whether software is regulated as a medical device in the United States, European Union and India.
Read the guidePredetics regulatory guides
Medical device software regulatory guides.
Detailed guidance on classification, FDA submissions, cybersecurity, software documentation and clinical evidence, with links to primary sources.
Written byPredetics Regulatory Editorial Team
Reviewed byMedical Device Regulatory and Quality Review
Current review cycleAug 31, 2026
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Start with the question you need to answer.
Each guide separates regulatory requirements from our recommendations and links to the relevant regulator, legislation or standards body.
02 · 13 min read
510(k) vs De Novo for SaMD: Choosing the Defensible FDA Path
Compare 510(k) and De Novo pathways for software as a medical device, from predicate fit and controls to review clocks, evidence and strategic risk.
Read the guide03 · 12 min read
FDA Pre-Submission Guide: Questions, Package and Realistic Timeline
Plan an FDA medical device Pre-Submission: when to use one, what to include, how to frame questions and how the official timeline works.
Read the guide04 · 15 min read
FDA Cybersecurity Guide: SBOM, Threat Models and Submission Evidence
Build connected medical device cybersecurity evidence for FDA: cyber-device applicability, threat modelling, SBOM, testing and postmarket plans.
Read the guide05 · 14 min read
IEC 62304 Documentation Guide: Build a Traceable SaMD File
A practical guide to IEC 62304 documentation for SaMD and medical device software, including safety class, plans, requirements, architecture, testing and maintenance.
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