# Healthtech / FDA Classification Checklist

- Product function and intended use:
- User population:
- Claims, marketing copy, labeling, and screenshots:
- General wellness / administrative / non-device CDS / device software / SaMD / accessory / other:
- Clinical decision support criteria analysis:
- AI-enabled device or adaptive model:
- Predetermined change control plan needed:
- Cybersecurity and SBOM evidence:
- Verification/validation and clinical evaluation:
- Postmarket monitoring and complaint handling:
- Emergency use limitations:
- Regulatory counsel decision and date: