Why FDA AI Matters to Timelines
Medicines. Under the Prescription Drug User Fee Act (PDUFA), FDA aims to act on new drug and Biologics License Applications within 6 months for priority files and 10 months for standard submissions, effectively a 6 to 10-month window.⁴
Software as a Medical Device (SaMD). For 510(k) clearances, the route AZmed’s Rayvolve® X-ray suite follows, the statutory review clock is 90 FDA days.⁵ In practice, iterative “additional-information” cycles frequently stretch total elapsed time to 180 days; if questions are not resolved within that period the file is withdrawn.
Most of that lag involves document-completeness checks, manual code-list comparisons and repetitive safety-endpoint queries, exactly the clerical busywork Elsa is designed to absorb. Internal modelling suggests that if Elsa trims even 25% of administrative “touch-time” (the gain observed in pilot testing), real-world clearance dates for imaging AI could advance by four to six weeks, with even larger effects on complex De Novo submissions.