Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in RAPS Regulatory Focus, in “FDA Should Step In to Help Spur AI/ML Standards,” by Ferdous Al-Faruque.
Following is an excerpt:
The US Food and Drug Administration (FDA) should support the burgeoning integration of artificial intelligence and machine learning (AI/ML) in medical devices by encouraging the development of new standards and setting deadlines for their implementation.
That’s according to Brad Thompson, a regulatory attorney at Epstein Becker Green. Thompson spoke with Regulatory Focus on the state of AI/ML and what can be done to help move the regulatory needle forward. While he supports organizations coming up with standards on their own, he says regulators should speed things up.
In the absence of clear expectation from the FDA, organizations such as Xavier University and private industry have stepped in to fill the gap with standards that address issues such as data requirements and integrity, Thompson said. On the government level, the National Institute of Standards and Technology is trying to do the same, he added.
To date, the FDA has relied on its 20 years of experience with imaging data to direct sponsors to guidances to understand data requirement needs – but that’s not enough, he said.
“I think FDA should encourage... standards organizations and industry bodies to really try and develop best practices that FDA can then incorporate by reference into their guidance documents, into their regulatory oversight,” said Thompson. “My concern with [the current] approach... is standards groups are notorious for how long they take to develop standards. They can easily spend years debating things before they get to a consensus decision.
“So maybe FDA has to put deadlines around the process to say, 'Look, we're going to decide what to do on this topic after this date and if you're a standards group and you want to have input, then get going and have something for us by that date, and then we'll decide,' " he added.
