Hardware
Pure Hardware Pathway
- • Class I: May be exempt from 510(k)
- • Class II — 510(k): Identify predicate, demonstrate substantial equivalence
- • Class II — De Novo: Novel low-mod risk, no predicate needed
- • Class III — PMA: High risk, full clinical evidence required
Key Standards: ISO 14971, IEC 60601, ISO 13485
AI/ML
AI/ML Device Pathway
- • Locked Algorithm: Standard 510(k) with AI-specific data requirements
- • Adaptive Algorithm: 510(k) + Predetermined Change Control Plan (PCCP)
- • Transparent CDS: May qualify as non-device software
- • Autonomous AI: High-scrutiny review, consider Breakthrough Device
Key: GMLP, PCCP, Cybersecurity, Dataset Documentation
SaMD
Software as Medical Device (SaMD)
- • Category I: Low risk — may be exempt or basic 510(k)
- • Category II: 510(k) + analytical & clinical performance evidence
- • Category III: 510(k) + clinical validation study
- • Category IV: Likely PMA — highest risk SaMD
Framework: IMDRF N12, IEC 62304, ISO 14971
SiMD
Software in Medical Device (SiMD)
- • Class A: No injury — basic documentation
- • Class B: Non-serious injury — moderate documentation
- • Class C: Death/serious injury — full verification
- • Cybersecurity assessment for network-connected devices
Key: IEC 62304, SOUP evaluation, SBOM, Cybersecurity