Building a successful 510(k) for Software as a Medical Device (SaMD) means proving substantial equivalence, showing safe performance, and providing evidence that aligns with FDA expectations.
Use this checklist as a starting point for SaMD submissions and adapt it to your device class, risk, and predicate strategy.
1) Positioning and predicate strategy
- Define intended use/indications for use and map to a clear device description.
- Identify a suitable predicate and explain substantial equivalence (technology, performance, clinical context).
- State limitations, contraindications, and user profile (HCP vs. patient-facing).
- Clarify software role (decision support vs. automation) and if human oversight exists.
2) Core 510(k) documents
- Cover letter and 351(k) statement (if applicable).
- Indications for use, device description, and comparison table vs. predicate.
- Truthful and Accuracy Statement, Class III Summary, and financial certification as needed.
- Labeling package: IFU, UI screenshots, warnings, symbols, UDI approach.
3) Software documentation (per FDA SaMD guidance)
- Level of concern/risk classification rationale and software architecture diagram.
- Software requirements spec with traceability to hazards and tests.
- Detailed description of algorithms, data inputs, model update policy, and versioning.
- Revision history, configuration management, and SOUP inventory with licenses.
- Cybersecurity documentation: threat model, SBOM, vulnerability handling, access control, logging.
4) Verification, validation, and usability evidence
- Unit/integration tests coverage summary and acceptance criteria.
- System-level verification traces to requirements; include key test reports.
- Usability validation per IEC 62366 and human factors findings/resolutions.
- Clinical/performance validation data (dataset representativeness, bias checks, statistics).
- Reliability testing (stress, failover, data loss prevention) and data integrity checks.
5) Risk management and QMS
- ISO 14971-compliant risk management file with hazard analysis and residual risk rationale.
- Software failure modes (FMEA/FTA) tied to mitigations and verification steps.
- Post-market surveillance plan and complaint handling flow.
- Quality system alignment with 21 CFR 820 (soon QMSR) and ISO 13485 controls.
6) Cybersecurity specifics for SaMD
- Authentication/authorization model, session controls, and least-privilege design.
- Data protection in transit/at rest, key management, secrets rotation.
- Secure update mechanism, rollback strategy, and vulnerability disclosure process.
- Logging/monitoring coverage and tamper detection.
7) How MedReg AI helps SaMD teams
- Upload your design history file to automatically highlight missing or weak sections against FDA SaMD expectations.
- Generate traceability between requirements, tests, and risk controls to tighten the risk management file.
- Produce a concise gap report you can share with RA/QA leadership before pre-sub or submission.
Next steps: run a gap analysis on your current package and align with your 510(k) predicate comparison. If you need pricing details, see /pricing or talk to us via /contact.
