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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:

  1. Significance of information provided (critical โ†’ serious โ†’ non-serious)
  2. 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.

Classification matrix โ€‹ SaMD grade is determined by combining two dimensions: โ€‹ โ€ข Significance of information: critical (treatment/diagnosis decisions) โ†’ serious (patient safety impacts) โ†’ non-serious (supportive information) โ€ข Healthcare situation: critical (life-threatening) โ†’ serious (serious illness) โ†’ non-serious (routine care) โ€‹ Critical/critical combinations typically result in Grade III or IV; serious/serious in Grade II or III; non-serious/non-serious in Grade I or exempt.

AI/ML SaMD examples โ€‹ Example use cases for PCCP: โ€ข Diagnostic imaging algorithms: pre-defined algorithm retraining based on validation datasets โ€ข Patient monitoring apps: predetermined updates to risk stratification models โ€ข Clinical decision support: pre-approved modifications to evidence-based scoring systems โ€‹ PCCP is not applicable to fundamental algorithm changes in mechanism of action, new intended uses, or expansion to new patient populations, which require new submissions.