Obtaining FDA approval can be a difficult and long process. “The traditional paradigm of medical device regulation was not designed for adaptive AI or ML technologies, which have the potential to adapt and optimize device performance in real – time to continuously improve healthcare for patients,” the report said.
“The highly iterative, autonomous, and adaptive nature of these tools requires a new, total product lifecycle (TPLC) regulatory approach that facilitates a rapid cycle of product improvement and allows these devices to continually improve while providing effective safeguards.”
If a manufacturer decides that its device that studies retinal scans for diabetic retinopathy can also measure if a patient has high blood pressure or not, it’ll have to contact FDA officials to check if the device can be used for that purpose.
This is probably a good space for that Talebian thinking that goes “start with what’s worked for thousands of years, and probably don’t stop.”