Practical worked examples of application forms and supporting documentation for IDATEN change control plan confirmation applications specific to SaMD. Illustrates how to describe proposed changes, set acceptance criteria, and prepare draft revised approval documents. Issued concurrently with the consolidated Q&A revision.

Consolidated revision of Q&A guidance on the IDATEN change control plan confirmation system, integrating three previously separate documents. Adds provisions specific to AI/ML-enabled medical devices and SaMD, requiring submission of procedures for developing and implementing the change control plan and materials for appropriate AI technology management. Reflects startup company needs and accumulated regulatory experience since the system's 2020 launch.

Practical guidance on expedited regulatory approval for SaMD including two-stage approval processes. Clarifies early marketing approval application handling across different development stages while maintaining consistent pre- and post-market safety/effectiveness assurance. Developed through public-private-academic collaboration as part of DASH for SaMD strategy, applicable to AI/ML-enabled SaMD.

Revision of 2021 SaMD classification guideline (2023 version). Clarifies and refines classification criteria based on accumulated consultation cases. Adds judgment criteria for AI/ML-enabled software, cloud-based programs, and wellness applications. Maintains alignment with IMDRF N10 and N12. Updates judgment flow based on intended use and risk.