News about GMP/cGMP

29.10.2021

US, Canada, and UK issue joint principles on Good Machine Learning Practice

US, Canada, and UK issue joint principles on Good Machine Learning Practice

The US FDA, Health Canada, and the British regulatory agency MHRA have jointly released 10 guiding principles to support the development of Good Machine Learning Practice (GMLP). As a basic framework it should help to promote safe, effective, and high-quality medical devices, while using AI (artificial intelligence) and ML (machine learning).


Being considered a rapidly progressing field, the principles should be used to:

  • Adopt good practices that have been proven in other sectors
  • Tailor practices from other sectors so they are applicable to medical technology and the health care sector
  • Create new practices specific for medical technology and the health care sector

The 10 principles read as follows:

 

All details to the guiding principles set out by the three agencies can be found here. Any feedback is welcome through the public docket at Regulations.gov.


Source:

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

 


 

Comments