Premarket Approval
Also called: PMA
The FDA's most demanding route, requiring clinical evidence of safety and effectiveness, used for the highest-risk devices and rare in medical AI.
Premarket approval requires the manufacturer to demonstrate reasonable assurance of safety and effectiveness through clinical evidence, usually including prospective trials. It applies to Class III devices, which are those supporting or sustaining life or presenting significant risk.
Very few AI devices have gone this route. The overwhelming majority are classified in a way that permits 510(k) or De Novo.
Where This Gets Misread
The rarity of PMA in medical AI is itself the finding. It means the evidence standard most clinicians assume sits behind "FDA approved" is almost never the standard these products actually met, and the word "approved" is usually being applied to a device that was cleared.