Networked Radiology Imaging and Treatment Planning Systems and FDA Cybersecurity Regulation: A Difference-in-Differences Analysis of 510(k) Clearance Delays.

Abstract

The objective of this study is to determine whether 510(k) clearance duration for AI-enabled devices changed differentially relative to the general market around October 1, 2023-the date FDA began Refuse-to-Accept enforcement of Section 524B cybersecurity documentation completeness-using a freshly re-extracted, complete FDA 510(k) dataset. We analyzed 83,675 FDA 510(k) records (De Novo excluded; decisions dated January 2000 through August 2, 2026). AI-enabled codes were identified via FDA's offi