RegDataLab is an independent FDA regulatory data platform built for AI agents and teams that need a structured view of public FDA records. Operated by Wasatch Crest Holdings LLC, it brings information from 37 datasets together and cross-references records by company and facility. Users can access the data through a single endpoint using either the Model Context Protocol (MCP) or a REST API.

Its coverage includes facility inspections and Form 483 citations, inspection outcomes, warning and untitled letters, recalls, import alerts and refusals, device 510(k) clearances and PMA approvals, drug shortages, NDC directory information, and structured product labeling. The platform also supports company-level summaries and tools for exploring underlying evidence, helping regulatory and compliance teams monitor enforcement, deal teams assess targets and suppliers, and quality professionals review manufacturers’ inspection histories and recall exposure.

RegDataLab offers API documentation, datasets, software, and pricing information, alongside a public demo and free API access. New users can try 50 calls without signup; verified users can receive 300 monthly credits.