FDA going soft on AI reviews?
Last Tuesday the FDA released an action plan telling how it will evaluate AI for medical applications going forward. Three days later the agency officially proposed letting numerous products through without review, as long as the product’s category hasn’t been historically associated with adverse events.
The Federal Register published the proposal last Friday. This week some observers are wondering where all of this is headed.
“It seems like very slippery slope territory to remove regulation,” Karandeep Singh, MD, MMSc, of the University of Michigan tells Stat News, which notes Singh’s research interests in medical AI. “With these kinds of devices, you’re not necessarily going to experience the side effect right away. It might take time to uncover issues with these products, so the absence of an adverse event being reported isn’t justification to completely waive all requirements.”
Stat News also paraphrases a senior HHS official who says Trump Administration was “deliberative in its approach and sought to create regulatory flexibility for developers of devices that stand to improve care. The official said the proposal allows for public comment and review of the exemptions for the AI devices and other products within that same risk category.”
As for where the proposal may go from here, Stat notes the uncertainty created by the transfer of power in the executive branch this week.
The Biden administration “would need to pursue and approve the policy for it to take effect for [the waived] devices,” Stat points out. “It is unclear whether it will do so.”
Read Stat’s full coverage here.
Dave P. has worked in journalism, marketing and public relations for more than 30 years, frequently concentrating on hospitals, healthcare technology and Catholic communications. He has also specialized in fundraising communications, ghostwriting for CEOs of local, national and global charities, nonprofits and foundations.