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FDA Data MCP

Manufacturing-first FDA intelligence for AI agents. Inspections, compliance actions, warning letters, OII records, import risk, facilities, and product data through one MCP endpoint.

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© 2026 FDA Data MCP · Wasatch Crest Holdings LLC
FDA Data MCP Blog

Engineering notes, data deep dives, and product updates.

Explore how FDA Data MCP ingests, normalizes, and connects FDA data for AI agents. Each post goes deeper than the docs and highlights implementation details.

Feb 7, 2026RegDataLab Team

Build a Company Profile with FDA Data MCP

How to assemble a complete company profile — aliases, facilities, enforcement, submissions, and a risk summary — in a single MCP call plus targeted drill-downs.

Feb 7, 2026RegDataLab Team

Find FDA-Registered Facilities by Company

Search for FDA-registered facilities by company name, drill into FEI-level details and risk summaries, and map facilities to device products.

Feb 7, 2026RegDataLab Team

Track FDA Enforcement Actions with MCP

Three complementary tools for tracking FDA recalls and enforcement actions — general enforcement, device-specific recalls, and iRES data — with sample responses and monitoring workflows.

Feb 7, 2026RegDataLab Team

Recall → Facility Trace

Link recalls to candidate manufacturing facilities using confidence-based matching. Understand confidence levels, interpret caveats, and build audit trails.

Feb 7, 2026RegDataLab Team

Monitor 510(k) Clearances with MCP

Track new 510(k) clearances by company or product code. Includes sample responses, product code lookups, and a monitoring workflow for competitive intelligence.

Feb 7, 2026RegDataLab Team

Monitor PMA Approvals with MCP

Track Pre-Market Approval decisions for Class III devices. Distinguish original PMAs from supplements, cross-reference product codes, and set up monitoring workflows.

Feb 7, 2026RegDataLab Team

Single-Company Monitoring Playbook

A practical, MCP-only playbook for monitoring a single company across facilities, recalls, submissions, drugs, and dashboard feeds.

Feb 7, 2026RegDataLab Team

FDA Dashboard: Compliance Actions + Import Refusals

How to query compliance actions and import refusals using FDA Data MCP dashboard tools.

Feb 7, 2026RegDataLab Team

FDA Dashboard: Inspections + Citations

How to query inspection classifications and citations using FDA Data MCP dashboard tools.

Feb 7, 2026RegDataLab Team

Drugs + NDC + Labels via MCP

How to use FDA Data MCP to search Drugs@FDA, NDC, product names, and structured labels.

Feb 6, 2026RegDataLab Team

13 New FDA Datasets: Drug Labels, Device UDI, Drug Shortages, and More

How FDA Data MCP expanded its underlying FDA coverage with labels, UDI, shortages, recalls, consumer and veterinary safety data, and the foundation for the newer manufacturing-compliance toolset.

Feb 4, 2026RegDataLab Team

Using AI to Analyze FDA Compliance Data: A Developer’s Guide

Step-by-step guide to connecting FDA Data MCP to Claude, Cursor, and other AI agents. Query FDA recalls, 510(k) clearances, inspections, and compliance data with natural language.

Feb 4, 2026RegDataLab Team

FDA 510(k) Clearance Statistics: Medical Device Approval Trends

In-depth analysis of FDA 510(k) clearance trends — volume by year, top companies, product code breakdowns, review times, AI/ML device clearances, and how to access 510(k) data programmatically via API.

Feb 4, 2026RegDataLab Team

FDA Drug & Device Recall Trends: What the Data Shows

Comprehensive analysis of FDA drug and device recall trends — Class I vs II vs III breakdown, year-over-year patterns, top recalled companies, root causes, and geographic distribution.

Feb 4, 2026RegDataLab Team

How FDA Data MCP Works

FDA Data MCP turns five messy FDA datasets into a single, queryable intelligence layer for AI agents. This deep dive explains the ingestion pipeline, normalization, alias resolution, and cross-referencing logic.