FDA Device Dataset
About the Dataset
The FDA Device Dataset is a comprehensive collection of data related to FDA-regulated medical devices. It includes information on device approvals, classifications, adverse events, recalls, and more, dating back to 1976. This dataset is updated daily, providing the most current information available from the FDA.
Key features of the dataset include:
510(k) Clearances
Device Classifications
Adverse Event Reports
Pre-market Approvals (PMA)
Recall Information
Registration and Listings
COVID-19 Serological Testing Evaluations
Unique Device Identifiers (UDI)
Dataset Features
Comprehensive Coverage: Includes data on all FDA-regulated devices since tracking began.
Daily Updates: All tables are refreshed daily to reflect the latest FDA information.
Historical Data: Device data dates back to 1976, providing a rich historical context.
Easily Queryable: Data is flattened for quick integration and analysis.
Diverse Event Types: Covers various device-related events from pre-market approval to post-market surveillance.
Data Quality and Maintenance
Daily updates ensure the most current FDA device information is available.
Automated data quality checks are implemented to maintain data integrity.
The dataset is monitored daily by the Dataplex Consulting team to ensure timely and accurate delivery.
Business Applications
Track pre-market FDA device approvals
Monitor and analyze device recalls
Identify firms associated with specific devices or events
Assess results of COVID-19 serology tests
Conduct market research on medical device manufacturers
Perform risk analysis on medical devices
Support regulatory compliance efforts
Example Use Cases
Analyze trends in 510(k) clearances for specific device types or manufacturers.
Investigate adverse events related to particular medical devices.
Track recall patterns for high-risk medical devices.
Assess the market landscape for specific device categories.
Conduct due diligence on medical device companies.
Data Structure
The FDA Device Dataset consists of multiple tables, each focusing on a specific aspect of medical device regulation. Key tables include:
DEVICE__510K_CLEARANCES
DEVICE__CLASSIFICATIONS
DEVICE__ADVERSE_EVENTS
DEVICE__PREMARKET_APPROVALS
DEVICE__RECALLS
DEVICE__REGISTRATIONLISTINGS
DEVICE__UDIS
Entity Relationship Diagram
Sample Queries
1. Count of 510(k) clearances for Class III devices by advisory committee
2. Recent recalls for a specific manufacturer
3. Adverse events related to a specific device type
Support and Contact
For questions, support, or assistance with the FDA Device Dataset, please contact:
Email: support@dataplex-consulting.com
Our team monitors ingestion and ETL jobs daily to ensure quality and timeliness of data delivery.
About Dataplex
Dataplex Consulting & Data Products is a comprehensive data consulting firm that empowers clients with reliable cloud data and analytics solutions. Our team of certified experts in data engineering and analytics offers tailored services to support data-driven enterprises.
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