The field of healthcare has been revolutionized by the use of artificial intelligence and machine learning technologies. These technologies have the potential to transform healthcare by deriving new insights from the vast amount of data generated during the delivery of healthcare every day. Medical device manufacturers are using these technologies to innovate their products to better assist healthcare providers and improve patient care.

The U.S. Food and Drug Administration (FDA) has been working to keep up with these rapid advancements in technology and has recently published a draft guidance document titled “Good Machine Learning Practice (GMLP) for Medical Device Development: Guiding Principles” to provide guidance to medical device manufacturers on the use of machine learning in medical devices.

Good machine learning practice (GMLP) is a set of guiding principles for the development and testing of machine learning algorithms. The principles are intended to help medical device manufacturers develop safe and effective machine learning-based medical devices. The guidance outlines best practices for designing, testing, and validating machine learning algorithms in medical devices.

The GMLP is centered around the principles of transparency, explainability, and robustness. These principles aim to ensure that medical devices using machine learning are accurate, reliable, and safe for patients. Machine learning algorithms are often thought of as “black boxes” as they can be difficult to interpret. The GMLP guidance aims to make the inner workings of these algorithms more transparent and explainable to users.

The guidance also highlights the importance of data quality in the development and training of machine learning algorithms. The data used to train algorithms must be high quality and representative of the population the medical device is intended for. The guidance also recommends that manufacturers document the data sources and curation processes used in algorithm development.

The GMLP guidance is a crucial step forward in ensuring the safety and effectiveness of machine learning-based medical devices. The principles outlined in the guidance provide a framework for manufacturers to test and validate these devices, which will ultimately lead to better patient outcomes.

The FDA is currently seeking public comment on the draft guidance, which will help shape the final version of the document. The FDA is also committed to continuing to engage with industry stakeholders to ensure that the guidance remains relevant and effective as new technologies emerge.

The GMLP guidance is an important step forward in ensuring that machine learning-based medical devices are developed in a safe and effective manner. By adhering to the principles of transparency, explainability, and robustness, medical device manufacturers can develop algorithms that are accurate, reliable, and safe for patients. The FDA’s commitment to engaging with stakeholders and continuing to update the guidance as new technologies emerge is a positive sign for the future of healthcare technology.