On October 24, 2023, the U.S. Food and Drug Administration (“FDA”), Health Canada, and the U.K.’s Medicines and Healthcare products Regulatory Agency (“MHRA”) jointly released a publication identifying five guiding principles for predetermined change control plans (“PCCP”) for machine learning-enabled medical devices (“MLMD Guiding Principles”).
Continue Reading FDA Releases Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding PrinciplesCHS Turns One & Unveils Trends in Transformations Blog
By Troy A. Barsky on
Posted in Health Policy
Crowell Health Solutions turns one and to celebrate is launching its own blog, Trends in Transformation. Below CHS recaps what the team accomplished in its first year and what the consultancy looks forward to achieving in 2023.
Continue Reading CHS Turns One & Unveils Trends in Transformations BlogFDA Publishes Principles for AI and ML in Medical Devices
By Crowell & Moring on
Posted in FDA
On October 27, 2021, the U.S. Food and Drug Administration (FDA) in collaboration with Health Canada, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), published Guiding Principles for the use of artificial intelligence and machine learning (AI/ML) in medical devices. The principles are designed to support good machine learning practices (GMLP) and to help promote safe, effective, and high-quality medical devices that use AI/ML. The FDA is accepting public comment on these principles on an ongoing basis.
Continue Reading FDA Publishes Principles for AI and ML in Medical Devices