Search Results for:


FDA Issues Guiding Principles for Good Machine Learning Practice for Medical Device Development

On October 27, 2021, the U.S. Food and Drug Administration (FDA), Health Canada and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a set of ten guiding principles meant to aid the development of Good Machine Learning Practice (GMLP). Artificial intelligence and machine learning (AI/ML) offers the…

Read More

List of Artificial Intelligence and Machine Learning (AI/ML)-enabled Devices Available on FDA’s Website

The U.S. Food and Drug Administration (FDA) now provides a list of Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices that are legally marketed in the United States. These include devices (1) cleared via 510(k) premarket notifications, (2) authorized pursuant to De Novo requests, and (3) approved via premarket approval applications, or…

Read More