FDA releases best practices for machine learning in medical device development News
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FDA releases best practices for machine learning in medical device development

The US Food and Drug Administration (FDA), Health Canada, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released ten guiding principles for the use of machine learning in medical device development. 

Artificial intelligence (AI) and machine learning technologies have become increasingly important in health care. According to FDA, these technologies have the potential “to transform health care by deriving new and important insights from the vast amount of data generated during the delivery of health care every day.” However, there are unique challenges surrounding the uses of these technologies, which is why the three entities collaborated on ten guiding principles.

These best practices, released Wednesday, include implementing sound software engineering and security practices, using clinical study participants and data sets that are representative of the intended patient population, and providing users with clear, essential information. These guiding principles will help promote safe, effective, and high-quality medical devices that use artificial intelligence and machine learning (AI/ML).

The entities envision that these principles will be used to adopt good practices from other sectors, tailor practices from other sectors and make them applicable to medical technology, and create new practices for medical technology. The principles are “intended to lay the foundation for developing Good Machine Learning Practice that addresses the unique nature of these products. They will also help cultivate future growth in this rapidly progressing field.”

On the collaborative effort between the three entities, MHRA stated:

We know that strong international partnerships will be (an) essential part of empowering the wider sector to advance responsible innovations. We look forward to our continued collaborative work and engagement with the FDA and Health Canada and wider international health partners in this area.

The FDA encourages feedback through the public docket at Regulations.gov, which can be accessed here.

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