The principals recommended by the three countries could be the foundation for how their regulatory bodies intend to regulate future AI/ML products.
US, Canadian and UK regulators have agreed upon a set of good machine learning practice (GMLP) principles that they want manufacturers to keep in mind when developing artificial intelligence/ machine learning (AI/ML) products. The principles echo some of the regulatory issues the agencies have faced in recent years.
The US Food and Drug Administration published the document titled, “Good Machine Learning Practice for Medical Device Development: Guiding...
“RRAs are valuable oversight tools and under certain circumstances, can assist FDA in its mission to protect public health, oversee regulated industry, and help ensure regulated products comply with FDA requirements,” according to final guidance.
A recent approval from the US FDA allowing Boston Scientific to broaden its labeling for its pulse field ablation system means more patients with one type of AFib will have access to a promising new treatment.
A revised annex to the original decision also outlines expert remuneration limits and introduces further changes.
