Devices

Machine Learning Principles for Device Development

FDA, working with Health Canada and the UK’s Medicines and Healthcare Products Regulatory Agency, has identified 10 guiding principles to inform the development of Good Machine Learning Practice (GMLP). An FDA statement says the principles will “help promote safe, effective, and high-quality medical devices that use artificial intelligence and machine learning.”

FDA says the principles identify areas where the International Medical Device Regulators Forum, international standards organizations, and other collaborative bodies could work to advance GMLP. Areas of collaboration, it says, include research, creating educational tools and resources, international harmonization, and consensus standards.

The statement says the agency envisions the principles being used to:

adopt good practices that have been proven in other sectors;
tailor practices from other sectors so they apply to medical technology and the healthcare sector; and
create new practices specific for medical technology and the healthcare sector.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome