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Public Policy Newsletter Article

FDA Releases AI/Machine Learning Action Plan

  • 2021-01-28T16:00:00.000+0000
  • Author: Izzie Ozmer

On January 12, FDA released its Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. This action plan is designed to allow for improved regulation of AI/ML devices, taking into consideration the devices’ specificities. In April 2019, FDA put out a draft plan, which outlined a pre-market review process for artificial intelligence and machine learning-driven software modifications and requested feedback from stakeholders. Biocom commented on this draft. Click here to see our comments. This final plan addresses the feedback received and aligns closely with the mission of the recently launched Digital Health Center of Excellence.

The plan could lead to faster and easier updates to devices (ie software updates) by monitoring real-world performance and business’ quality system practices. While the plan and any consecutive guidances could improve the approval process, it may also lead to an increase in oversight in the functioning of devices.

The plan looks at five areas of feedback from the initial discussion paper: Tailored Regulatory Framework for AI/ML-based SaMD, Good Machine Learning Practice (GMLP), Patient-Centered Approach Incorporating Transparency to Users, Regulatory Science Methods Related to Algorithm Bias & Robustness, and Regulatory Science Methods Related to Algorithm Bias & Robustness.

The tailored framework is a key area of interest, and FDA intends to issue a draft guidance in this area. The draft discussion paper explained that the proposed framework includes a “Predetermined Change Control Plan (PCCP).” This PCCP would be made up of SaMD Pre-Specifications (SPS) that describe "what" aspects the manufacturer intends to change, and the Algorithm Change Protocol (ACP), which explains "how" the device will change while remaining safe and effective.

If you have any questions or feedback on this action plan, please contact Biocom’s Regulatory Policy Associate, Isabel Omer, at [email protected].