Data Sources & Attribution
Where our information comes from
📋 Public Domain Government Data
All device information in What's In Me? comes from publicly available U.S. Food and Drug Administration (FDA) databases. This data is considered public domain and is freely available to researchers, healthcare providers, and the general public.
Primary FDA Data Sources
GUDID (Global Unique Device Identification Database)
The FDA's comprehensive database of medical device identifiers and basic safety information.
Contains: Device identifiers, basic device information, MRI safety labeling
Updated: Continuously by manufacturers as required by FDA
Access: https://accessgudid.nlm.nih.gov/
MAUDE (Manufacturer and User Facility Device Experience)
Database of adverse events and product problems reported to the FDA.
Contains: Adverse event reports, device malfunctions, recalls
Updated: Monthly by FDA
Access: FDA MAUDE Database
510(k) Premarket Notification Database
Database of medical devices cleared for market through the 510(k) pathway.
Contains: Device clearance information, intended use, predicate devices
Updated: As new devices receive clearance
Access: FDA 510(k) Database
PMA (Premarket Approval) Database
Database of high-risk medical devices that have received FDA premarket approval.
Contains: Detailed safety and efficacy data for Class III devices
Updated: As new devices receive approval
Access: FDA PMA Database
How We Collect and Process Data
Our Data Pipeline:
Automated Data Scraping
We use automated scripts to regularly download data from FDA public APIs and databases. This includes device records, safety information, and recall notices.
Data Parsing and Standardization
Raw FDA data is processed to extract relevant fields, standardize formats, and cross-reference between different databases (matching GUDID records with MAUDE reports, for example).
Manual Curation and Quality Checks
Our team manually reviews device records for accuracy, adds missing information where possible, and flags potential data quality issues for further investigation.
Database Integration
Processed data is integrated into our search database with full-text indexing to enable fast searches across device names, manufacturers, and model numbers.
Data Update Schedule
Automated Updates
- • GUDID: Weekly refresh
- • MAUDE: Monthly (following FDA releases)
- • Recalls: Daily monitoring
- • 510(k) & PMA: Weekly refresh
Manual Reviews
- • Data quality: Ongoing
- • User reports: Within 48 hours
- • Manufacturer updates: As received
- • Database maintenance: Monthly
Trademark and Manufacturer Information
Nominative Fair Use Notice
Manufacturer names, product names, trademarks, and device identifiers displayed throughout What's In Me? are used under the doctrine of nominative fair use for identification and informational purposes only.
Such use does not imply endorsement by, sponsorship by, or affiliation with the respective manufacturers. We use these identifiers because:
- They are necessary to identify specific medical devices
- They enable patients and providers to locate accurate safety information
- No alternative generic terms would adequately identify the specific products
- We use only the minimum necessary identification information
All trademarks, service marks, and trade names remain the property of their respective owners.
Data Accuracy and Limitations
Important Limitations:
- Source data accuracy: We cannot guarantee the accuracy of data provided by manufacturers to the FDA
- Processing errors: Automated data processing may introduce formatting or parsing errors
- Update delays: Changes to FDA databases may not be immediately reflected in our system
- Incomplete records: Some devices may have partial or missing information in FDA databases
- Manufacturer changes: Device specifications may change without corresponding FDA database updates
⚠️ Always verify critical safety information directly with device manufacturers and healthcare providers.
Report Data Errors or Concerns
Help Us Improve Data Quality
If you notice incorrect, outdated, or missing device information, please let us know. We investigate all reports and work to correct verified data issues.
When reporting data issues, please include:
- Device name and manufacturer
- Model/catalog number if available
- UDI (Unique Device Identifier) if known
- Specific issue or concern
- Source of correct information (manufacturer website, IFU, etc.)
Research and Academic Use
Data Access for Researchers
Since our data comes from public FDA sources, researchers and academics are welcome to reference our compiled information. However, we recommend citing original FDA databases for formal research:
- GUDID: Cite as "FDA Global Unique Device Identification Database (AccessGUDID)"
- MAUDE: Cite as "FDA Manufacturer and User Facility Device Experience Database"
- 510(k): Cite as "FDA 510(k) Premarket Notification Database"
- PMA: Cite as "FDA Premarket Approval (PMA) Database"
For bulk data access or research partnerships, contact us atsupport@whatsinme.life.