FDA: Plan for Oversight with ML/AI in Medical Devices :

CONTEXT: FDA publishing an action plan on AI in SAAMDs. China already
ahead of the game in terms of how they have already enacted guidance on AI in SAAMDs, but this is good to see the US getting to grips with an
important regulatory grey area in medical devices.

READ TIME: 2 mins

FDA Discussion Paper: Proposed Regulatory Framework for Modifications to
Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a
Medical Device (SaMD) – Discussion Paper and Request for Feedback

*1. “On January 12, 2021, the U.S. Food and Drug Administration (FDA)
released the Artificial Intelligence/Machine Learning (AI/ML)-Based
Software as a Medical Device (SaMD) Action Plan (Action Plan).” *

*2. “The Action Plan expresses that the “FDA’s vision is that, with
appropriately tailored total product lifecycle-based regulatory oversight,
AI/ML-based Software as a Medical Device (SaMD) will deliver safe and
effective software functionality that improves the quality of care that
patients receive.”” *

*3. “Led by the FDA Center for Devices and Radiological Health’s (CDRH)
Digital Health Center of Excellence, the Action Plan expands on concepts
outlined in the 2019 Discussion Paper, “Proposed Regulatory Framework for
Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based
Software as a Medical Device (SaMD),” which describes a potential approach
to premarket review for AI/ML-driven software modifications.” *

*4. “The FDA intends to issue draft guidance in 2021 for public comment on
the Predetermined Change Control Plan, including a content proposal for
SaMD Pre-Specifications (SPS) and Algorithm Change Protocol (APS), what
types of modifications are appropriate, and the specifics of the Focused
Review Process.” *

*5. “The FDA will encourage further harmonization of Good Machine Learning
Practices (GMLP) development by increasing its participation in various
communities dedicated to its creation, including the International Medical
Device Regulators Forum (IMDRF) Artificial Intelligence Medical Devices
(AIMDs) Working Group and International Organization for Standardization/
Joint Technical Committee 1/ SubCommittee 42 (ISO/ IEC JTC 1/SC 42) –
Artificial Intelligence.” *

Source URL:
https://www.jdsupra.com/legalnews/fda-announces-action-plan-for-oversight-5927745/

ALT URL: https://www.fda.gov/media/122535/download