- For Immediate Release:
The following quote is attributed to Bakul Patel, director of the FDA’s Digital Health Center of Excellence in the Center for Devices and Radiological Health
“With artificial intelligence and machine learning progressing so rapidly, our three regulatory agencies, together, see a global opportunity to help foster good machine learning practice by providing guiding principles that we believe will support the development and maturation of good machine learning practice. This will help stakeholders to advance device development, which has the potential to significantly improve the quality of patient care and transform health care.
We recognize that machine learning technologies present unique considerations due to their complexity and the iterative and data-driven nature of their development. While this is true, we are excited for continued progress in this area. We believe these guiding principles will help advance the development of machine learning technologies for medical devices.
We also recognize that strong partnerships with our international public health partners are essential for the FDA’s Digital Health Center of Excellence efforts. Such partnerships empower stakeholders to advance responsible innovations and we expect this initial collaborative work with Health Canada and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) can inform our broader international engagements, including work at the International Medical Device Regulators Forum.”
- Today, the U.S. Food and Drug Administration, Health Canada and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) jointly issued the “Good Machine Learning Practice for Medical Device Development: Guiding Principles” to identify a set of ten guiding principles that are important to be included in the development of Good Machine Learning Practice (GMLP). Good Machine Learning Practice is intended to advance high quality artificial intelligence/machine learning enabled medical device development.
- These ten principles are intended to identify areas where alignment in efforts related to research, building resources and tools, regulatory policies, regulatory guidelines, international harmonization and consensus standards could be developed by the International Medical Device Regulators Forum (IMDRF), international standards organizations and other collaborative bodies to advance the maturation of GMLP.
- The FDA envisions that these guiding principles could be used to either specifically tailor practices applicable to health care, create new practices for health care or adopt from practices that have been proven in other domains.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
- Jim McKinney