WASHINGTON—The U.S. Food & Drug Administration, Health Canada and the United Kingdom’s Medicines and Healthcare products Regulatory Agency have jointly identified 10 guiding principles that can help manufacturers build safe, effective and high-quality medical devices that enable artificial intelligence and machine learning.
According to the FDA, the just-released principles should help "cultivate future growth in this rapidly progressing field.” The agency also hopes the principles help tailor practices from other sectors so they are applicable to medical technology and the healthcare sector.
"These guiding principles are useful for medical device manufacturers insofar as they codify what needs to be developed and how," comments Bill Betten, director of solutions for medtech at S3 Connected Health. "They provide much-needed rigor and structure, and that’s no simple task given the wide set of conditions they cover and the speed of development in this area. It’s a good, very necessary, first step.
"One of the key challenges now is for medical device manufacturers to be extremely clear on the methods of data capture or generation," continues Betten. "We can’t just assume that data is gathered and analyzed by the same company, since frequently, it isn’t.
The FDA's first Industry Discussion Paper on machine learning was launched back in 2019, followed by an Action Plan in 2021 aimed at offering guidance on the topic.