Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in MedTech Dive, in “FDA Unveils Framework for AI-Based Medical Devices,” by David Lim.
Following is an excerpt:
FDA Commissioner Scott Gottlieb Tuesday unveiled a proposed framework to allow ongoing artificial intelligence algorithm changes based on real-world learning. Modifications to traditional software as a medical device (SaMD) that could have a significant impact on the safety or effectiveness of a device would still require a submission to FDA. …
Epstein Becker Green device attorney Brad Thompson points out FDA admits in the discussion paper that additional statutory authority may be needed to fully implement such an idea.
“I am worried a bit that FDA is becoming really good at coming up with ideas and not so good about carrying through with them,” Thompson told MedTech Dive in an email. “It’s unclear whether they are saying that certain portions of this idea can be implemented right away through guidance, while others may have to await legislation.” …
While Thompson remains concerned how both the new AI framework and FDA’s Software Precertification Program will be implemented, he praised FDA for its pursuit of innovative regulatory approaches for new technologies like AI.
“I just hope that the agency can carry through with some of these new initiatives all the way to completion,” Thompson said. “Between the two programs – precertification and this new AI initiative – speaking personally I think I’m more excited about the new AI initiative.”