The Food and Drug Administration is preparing formal policy guidance covering medical devices that incorporate generative AI, according to Rick Abramson, director of the agency's Digital Health Center of Excellence. "Our goal is formal policy guidance. The ecosystem is expecting clarity," Abramson said, adding that the FDA plans both "broad guidance on the overall topic of generative AI" and "specialty guidance on particular generative AI topics."
The announcement responds to mounting pressure from device makers who say the current regulatory landscape leaves them guessing about how to bring generative AI products to market, particularly tools that generate clinical text, imaging interpretations or treatment suggestions rather than simply classifying data. Traditional FDA device frameworks were largely built around more predictable, narrowly scoped software.
Abramson did not specify a timeline for when the guidance documents will be released. The move follows a broader pattern this year of the FDA revisiting its oversight approach to AI-enabled devices and wearables, as regulators try to balance faster innovation against the unpredictability that comes with generative models.
