Disclosure of guidance-recommended information in FDA decision documents for AI-enabled devices before and after the 2025 draft guidance: data and code

Reproducibility package for an interrupted time-series study of public disclosure in 977 FDA decision documents for AI-enabled devices before and after FDA’s 7 January 2025 draft guidance. Version 1.2 adds the post hoc computational audit scripts, inputs and outputs, the corrected Figure 2 and revised Figure 4, and a fix so reruns do not overwrite the freeze record. Data and the primary analysis are unchanged from version 1.1. All document classifications were generated by AI agents; no human verified them.