FDA Issues Machine Learning-Enabled Medical Device Transparency Principles

The FDA, Health Canada and the UK Medicines and Healthcare products Regulatory Agency (MHRA) have issued guiding principles for transparency for machine learning-enabled medical devices (MLMD).

The transparency principles build on the ten guiding principles for good machine learning practice (GLMP) identified by the three agencies in 2021. Those principles support the development of safe, effective and high-quality AI/machine learning technologies that can learn from real world use and improve device performance.

In the document, the agencies explain that “‘transparency’ describes the degree to which appropriate information about a MLMD (including its intended use, development, performance and, when available, logic) is clearly communicated to relevant audiences. ‘Logic’ refers to information about how an output or result was reached or the basis for a decision or action. The degree to which this logic can be explained in a way that a person can understand is known as ‘explainability.’ Logic and explainability are aspects of transparency.”

Read the guiding principles here.

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