SaMD โ MFDS Policy
MFDS has developed a comprehensive SaMD framework aligned with the IMDRF SaMD N10, N12, and N23 documents.
Classificationโ
SaMD grade determined by:
- Significance of information provided (critical โ serious โ non-serious)
- Healthcare situation (critical โ serious โ non-serious)
Not regulatedโ
- Administrative software (EHR scheduling, billing)
- General wellness apps with no medical purpose
- Simple communication tools
Predetermined Change Control Plan (PCCP)โ
MFDS is developing PCCP guidance for AI/ML SaMD โ allowing manufacturers to pre-define future algorithm changes that do not require a new submission.