What FDA Software as a Medical Device (SaMD) Risk Matrix requires
A risk-based framework for classifying software intended for medical purposes independently of hardware, based on IMDRF categorizations and FDA safety standards.
Pillar: Medical & Healthcare · Authority: US Food and Drug Administration (FDA) · Version: 1.1.0 · Last updated:
Primary source: https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd
SHA-256 integrity: e614f5880fbd39c98cfaf523d531a70ae0562d3e0be3a2f15a716f43b52f4654
Primary Citations — 6 traced to source
- IMDRF/SaMD WG/N12FINAL:2014 - 'Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations'
- FDA Guidance for Industry and Food and Drug Administration Staff: 'Software as a Medical Device (SAMD): Clinical Evaluation' (2017)
+ 4 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.
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