Six documents that take you from SaMD classification through regulatory pathway selection, 510(k) predicate analysis, and post-market planning — built for RA professionals who can't afford to get it wrong.
For RA/QA at SaMD companies and digital health startups.
FDA's digital health policy, IMDRF's 4-category framework, and EU MDR's Rule 11 all classify the same software differently. Getting the wrong classification means choosing the wrong regulatory pathway, which costs months and six figures.
Most SaMD teams spend weeks in spreadsheets, reading guidance documents that don't give clear answers. This toolkit gives you decision logic, not just definitions — so you can classify, select a pathway, and start your submission with confidence.
Structured in the order you build a SaMD regulatory file.
IMDRF framework-based classification worksheet with FDA and EU MDR mapping. Determine your SaMD risk category (I–IV) with step-by-step decision logic, significance of information output, and healthcare decision mapping. Covers FDA Digital Health Policy and EU MDR Rule 11.
FDA-structured template differentiating Intended Use from Indications for Use for SaMD submissions. Pre-formatted for 510(k) Section 2, De Novo requests, and EU MDR intended purpose documentation. Includes examples for clinical decision support, diagnostic, and monitoring software.
IEC 62304-aligned software description covering system architecture, software items, SOUP identification, and operating environment. Structured to satisfy FDA's Software Documentation guidance and EU MDR Annex I §17 software requirements. Maps to 510(k) Section 14.
Systematic 510(k) predicate analysis worksheet for SaMD. Covers intended use comparison, technological characteristics, software function equivalence, and substantial equivalence argument. Includes IMDRF category cross-reference for predicate qualification.
Decision-tree roadmap comparing FDA (510(k), De Novo, PMA, EUA), EU MDR (Class I–III, Notified Body), and Health Canada (Class II–IV) pathways. Includes timeline estimates, clinical evidence requirements, and real-world selection criteria for each jurisdiction.
EU MDR Annex XIV Part B compliant PMCF plan for software devices. Addresses SaMD-specific data sources (app analytics, user feedback, registry data, literature), surveillance intervals, and safety signal escalation. Includes FDA post-market monitoring cross-reference.
All templates cross-reference IMDRF SaMD classification, FDA digital health policy, IEC 62304, and EU MDR Rule 11. One set of documents covers every major jurisdiction.
SaMD regulatory strategy can stall for months when teams don't know which pathway applies. This toolkit gives you the decision logic, not just definitions.
Every template is structured to produce deliverables regulatory reviewers and notified bodies actually accept — not generic frameworks you have to reverse-engineer.
Stripe checkout. Instant download after payment.
“We were burning weeks trying to reconcile FDA's digital health policy with EU MDR Rule 11. This classification worksheet mapped both frameworks side by side and we had our SaMD category locked in a single afternoon. The regulatory roadmap alone saved us from pursuing a De Novo when a 510(k) was the right path.”
Michael R., VP Regulatory Affairs — Clinical Decision Support SaMD Company, Boston MA
“The Intended Use template was exactly what our product team needed. There's always confusion between intended use and indications for use — especially in software. Having a pre-structured template with examples from real CDS submissions made the 510(k) drafting process so much faster.”
Anja V., Senior Regulatory Affairs Specialist — EU MDR Digital Health Startup, Munich
“We're a small team without a dedicated RA consultant. The SaMD Classification Worksheet and Roadmap gave us enough structure to have an informed conversation with our notified body before spending €15K on a gap assessment. Worth every cent.”
David S., Head of Quality & Regulatory — SaMD Startup, Toronto
FDA uses device classification (Class I, II, III) combined with Digital Health Center of Excellence guidance, while IMDRF uses a 4-category SaMD risk framework based on significance of information and healthcare situation. Document 01 maps both side by side with decision logic so you know which regulatory classification governs your submission pathway.
It depends on whether a valid predicate exists for your SaMD's intended use. 510(k) requires substantial equivalence to a cleared device. De Novo is for novel low-to-moderate risk devices with no valid predicate. Document 04 (Predicate Analysis) helps you determine predicate availability, and Document 05 (Regulatory Roadmap) outlines the De Novo vs 510(k) decision criteria.
Document 03 (Software Description Document) is IEC 62304-aligned and maps to FDA's Software Documentation guidance. It covers software safety classification (Class A/B/C), SOUP identification, and architecture documentation. For a complete IEC 62304 software development lifecycle toolkit, see our SaMD Regulatory Toolkit.
Yes. Document 01 includes a Rule 11 decision tree for EU MDR software classification (Class I, IIa, IIb, III) based on intended purpose and information significance. It maps directly to EU MDR Annex VIII alongside the IMDRF risk category framework.
No. This is a practitioner reference toolkit. Templates and frameworks reflect current FDA guidance, IEC 62304, IMDRF, and EU MDR 2017/745 requirements, but your specific device and submission require review by qualified regulatory professionals. Consult your RA team or regulatory counsel for formal compliance opinions.
Start with the right classification. Choose the right pathway. Build a submission-ready regulatory file.
Also: SaMD IEC 62304 Lifecycle Toolkit $247 · Full Suite $997