JD Supra

FDA Publishes Machine Learning Transparency Guiding Principles for Medical Devices

The Transparency Principles emphasize the effective communication of relevant information about a MLMD to users, such as the intended use(s), device development, device performance, and method for ...
JD Supra

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 ...
RAPS

IMDRF drafts framework on best practices for using AI in medical devices

The International Medical Device Regulators Forum (IMDRF) has released a draft technical document to create a harmonized set of best practices in mitigating risks associated with the use of artificial ...