An analysis of all 1,483 AI/ML-flagged records in the Innolitics FDA Device Explorer found 88 AI software-as-a-medical-device clearances that cite a predicate which is not SaMD, and 50 of those are ca…
Innolitics partner David Giese, who has helped bring 35+ AI-enabled diagnostic devices to the US market, published a guide on FDA Pre-Submissions, noting that the FDA currently charges no fee for Pre-…
A new analysis by Innolitics of 890 FDA clearance letters for AI/ML software-as-a-medical-device authorizations through August 2026 finds that 57 percent name an in-house regulatory or quality person,…
One in five AI/ML 510(k) clearances cites a predicate under a different product code, with 85 devices predicated on a different body region, 35 swapping imaging modality, and 122 crossing 21 CFR regul…
The U.S. Food and Drug Administration (FDA) has introduced Predetermined Change Control Plans (PCCPs) as a regulatory tool allowing companies to pre-clear certain device changes within a 510(k), De No…