The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency have issued joint guidelines for companies creating medical devices that use artificial intelligence. The guidelines issued by the three governmental agencies are designed to inform the development of good machine learning practice (GMLP) and promote safe, effective, and high-quality medical devices that use artificial intelligence and machine learning (AI/ML).
Ten guiding principles have been identified addressing the unique nature of AI/ML products:
- Multi-disciplinary expertise is leveraged throughout the total product life cycle
- Good software engineering and security practices are implemented
- Clinical study participants and data sets are representative of the intended patient population
- Training data sets are independent of test sets
- Selected reference datasets are based upon best available methods
- Model design is tailored to the available data and reflects the intended use of the device
- Focus is placed on the performance of the human-AI team
- Testing demonstrates device performance during clinically relevant conditions
- Users are provided clear, essential information
- Deployed models are monitored for performance and re-training risks are managed
The FDA believes the 10 guiding principles will help cultivate future growth in this rapidly progressing field. Areas of expected collaboration among the governments include research, creating educational tools and resources, international harmonization, and consensus standards, all of which may help inform regulatory policies and regulatory guidelines. The FDA believes the guiding principles may be used to adopt good practices that have been proven in other sectors; to tailor practices from other sectors so they are applicable to medical technology and the health care sector; and to create new practices specific to medical technology and the health care sector.
The FDA is enthusiastic about this collaboration with its international public health partners, which it believes "will be crucial if we are to empower stakeholders to advance responsible innovations in this area."