MITA applauds FDA for AI medical device principles


The FDA, along with Health Canada and the United Kingdom’s Medicines and Healthcare products Regulatory Agency, published “Good Machine Learning Practice for Medical Device Development: Guiding Principles” in an effort to promote “safe, effective, and high-quality” devices using AI.


The guidance hastens patient access to AI technologies, according to Patrick Hope, MITA executive director. He also wrote that MITA looks forward to working with the FDA on best use of these guidelines.


In its submitted comments, MITA also asked the FDA to engage industry stakeholders and work collectively…



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