On January 18th 2021, the US Food and Drug Administration (FDA) released a five-part action plan for their artificial intelligence and machine learning (AI/ML) software and classified it as a medical device (SaMD).  They hope to develop a tailored regulatory framework for the medical device by releasing  a draft guidance which outlines a premarket review for AI/ML based SaMD modifications.

This guidance is expected to be published this year. It will draw on practices from pre-existing premarket programs in the US as well as risk categorizations principles from international medical device regulators programs.

About the AI/M Pre-market Review:

The guidance will discuss which elements need to be included in the pre-specifications and ACP to ensure safety and efficacy; as well as identification of types of modifications, submission and review processes for premarket review, and submission content.

The change control plan allows manufacturers to prespecify the modifications to the AI/ML SaMD as it changes over time through an algorithm.

The Algorithm change Plan Protocol explains how algorithm learns and changes without comprising the medical software’s safety and effectiveness. The algorithmic aspect will use collaborative regulatory science research and methods to evaluate AI.ML software

The remaining action plan includes good machine learning practice, use of patient centered approach that includes transparency to SaMD, improving methods for evaluating and addressing algorithm to ensure robustness and real-world performance monitoring for AI/ML software. Real world data will be key components of the final product lifecycle.

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About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices , pharmaceutical, cosmetic and food supplement companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.  

United States' FDA

FDA's responsibilities are closely related to those of several other government agencies. In general, FDA regulates: Foods, Drugs, Biologics, Medical Devices, Electronic Products that give off radiation, Cosmetics, Veterinary Products, Tobacco Products.

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