Does this skill provide medical device classification data?

Yes, it allows you to look up device classifications, search 510(k) clearances, PMA approvals, and Unique Device Identification (UDI) data.

Is the data returned by this skill real-time?

The skill queries the openFDA API, which is updated regularly by the FDA, though there may be a lag between reporting and database ingestion as per FDA's standard processing times.

Do I need an API key to use this FDA database skill?

While the skill works without a key for low-volume queries (1,000/day), registering for a free openFDA API key is recommended to increase limits to 120,000 requests per day.

Can I perform temporal trend analysis with this tool?

Yes, the skill includes patterns for querying data across specific date ranges, allowing you to analyze adverse event trends over months or years.

What specific FDA endpoints can I query?

You can access endpoints for human drugs, medical devices, food, animal and veterinary products, and chemical substances (UNII/CAS mapping).

FDA Regulatory Data Access

Name: FDA Regulatory Data Access
Author: x-cmd

byx-cmd

•

データサイエンスとML

Queries the openFDA API to retrieve comprehensive data on drugs, medical devices, foods, and regulatory actions for safety research and analysis.

概要

This skill provides a standardized Python interface to the openFDA API, enabling developers and researchers to programmatically access vast datasets including adverse events, product labeling, recalls, and regulatory submissions. It streamlines the process of gathering pharmacovigilance data, device classifications, and food safety information, making it an essential tool for regulatory compliance, scientific research, and safety signal detection. By offering structured query patterns for safety profiles and temporal trends, it simplifies complex regulatory data analysis directly within your AI-assisted workflow.

主な機能

Substance identification and chemical structure mapping using UNII and CAS codes
8 GitHub stars
Real-time monitoring of product recalls, enforcement actions, and drug shortages
Comprehensive access to drug, device, food, and veterinary safety endpoints
Advanced search patterns for adverse event trends and comparative safety analysis
Standardized Python interfaces for simplified API querying and automated pagination

ユースケース

Conducting pharmacovigilance to detect safety signals and adverse drug reactions
Researching food safety incidents and allergen-related enforcement reports
Monitoring medical device recalls and tracking 510(k) or PMA approval pathways

概要

主な機能

Substance identification and chemical structure mapping using UNII and CAS codes
8 GitHub stars
Real-time monitoring of product recalls, enforcement actions, and drug shortages
Comprehensive access to drug, device, food, and veterinary safety endpoints
Advanced search patterns for adverse event trends and comparative safety analysis
Standardized Python interfaces for simplified API querying and automated pagination

ユースケース

Conducting pharmacovigilance to detect safety signals and adverse drug reactions
Researching food safety incidents and allergen-related enforcement reports
Monitoring medical device recalls and tracking 510(k) or PMA approval pathways