What device-specific information can I retrieve?

You can query 510(k) clearances, Premarket Approvals (PMA), UDI information, device classifications, and malfunction reports.

Do I need an API key for the FDA Database skill?

While it works without a key (1,000 requests/day), obtaining a free key from open.fda.gov increases your limit to 120,000 requests per day.

Can this skill help with drug safety research?

Yes, it provides specific patterns for temporal trend analysis and comparative safety profiles using adverse event reports and labeling data.

What data sources does this skill access?

It accesses the openFDA API, covering drugs, medical devices, food safety, veterinary products, and chemical substance databases.

Is the data returned in a standardized format?

Yes, all queries return structured JSON data with consistent metadata for results count, pagination, and disclaimers.

FDA Regulatory Data Analysis

Name: FDA Regulatory Data Analysis
Author: jimmc414

byjimmc414

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324

Data Science & ML

Accesses and analyzes comprehensive FDA regulatory data for drugs, medical devices, and food safety through the openFDA API.

About

This skill provides a specialized Python interface for interacting with the openFDA database, enabling researchers and developers to query drug adverse events, medical device clearances, food recalls, and substance identifiers. It streamlines the process of extracting regulatory data, performing pharmacovigilance, and conducting safety signal detection directly within the Claude Code environment. By offering standardized query patterns for drugs, devices, and veterinary products, it facilitates complex scientific research, compliance monitoring, and data-driven discovery tasks.

Key Features

Automated rate limiting and caching for efficient API consumption
Food and dietary supplement safety and recall monitoring
Substance identification using UNII, CAS, and chemical structures
Comprehensive drug safety, labeling, and shortage query endpoints
324 GitHub stars
Medical device surveillance including 510(k) clearances and PMA data

Use Cases

Automating pharmacovigilance and safety signal detection for pharmaceutical research
Tracking medical device regulatory lifecycles and historical recall data
Analyzing food safety trends and allergen-related enforcement actions

About

Key Features

Automated rate limiting and caching for efficient API consumption
Food and dietary supplement safety and recall monitoring
Substance identification using UNII, CAS, and chemical structures
Comprehensive drug safety, labeling, and shortage query endpoints
324 GitHub stars
Medical device surveillance including 510(k) clearances and PMA data

Use Cases

Automating pharmacovigilance and safety signal detection for pharmaceutical research
Tracking medical device regulatory lifecycles and historical recall data
Analyzing food safety trends and allergen-related enforcement actions