FDA Draft Guidance for AI/ML

On April 3, 2023 FDA release guidance around making changes to Artificial Intelligence (AI) and Machine Learning (ML) models categorized as Software as a Medical Device (SaMD) or as FDA calls it machine learning enabled software functions (ML-DSFS)In this draft guidance FDA lays out a new plan that can be submitted during your initial applications for premarket approval/notifications called the Predetermined Change Control Plan (PCCP). A PCCP can document a
– Data management practices
– Re-training practices
– Validation practices
– Performance evaluation
– Update proceduresOnce approved as part of the initial application, a manufacturer can then make modifications to the machine learning algorithm as long as it falls within the parameter of the authorized PCCP, the manufacturer will not need to resubmit a new application. Instead, the changes can be documented in accordance with the quality management system and authorized PCCP.This is a step in the right direction for the FDA to allow for broader adoption of the AI/ML techniques in medical devices. Like any draft there are some quirks and hopefully FDA cleans them up before the finalization of the guidance.

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