FDA Database for Research
Access one of the most comprehensive structured FDA medical device regulation datasets available for research. Our RegulationCard database contains over 2,469 FDA regulations, 69,496 unique 510(k) clearances, 5,308 product codes, and extensive safety data—perfect for academic research, regulatory science, and medical device studies.
Comprehensive Regulatory Dataset Statistics
Our structured regulatory dataset is one of the most extensive collections of FDA medical device regulatory data available for research. This data warehouse provides researchers, academics, and institutions with unprecedented access to organized regulatory information.
Data as of: December 2025. Statistics are updated regularly as new regulations, clearances, and safety data are added to the collection.
Regulatory Dataset Contents
This structured regulatory corpus contains comprehensive data across multiple regulatory dimensions:
FDA Regulations
2,469 complete FDA regulations (21 CFR) with full text, identification, special controls, exemptions, and regulatory history. All regulations include classification metadata, panels, and device classes.
Product Codes
5,308 unique FDA product codes with device names, definitions, device classes (I, II, III), panels, typical technology signals, and intended use descriptions.
510(k) Predicates
69,496 unique 510(k) clearances with K-numbers, device names, applicants, decision dates, substantial equivalence determinations, and 23,395 with full text summaries.
Standards
12,404 standard references including ISO, IEC, ASTM standards with numbers, editions, organizations, recognition dates, and provenance tracking.
Guidance Documents
211 unique FDA guidance documents with 172,447 guidance-to-regulation mappings, titles, URLs, status (active/withdrawn), and relevance tags.
Safety Data
34,942 product recalls (Class I, II, III), 5,308 MAUDE adverse event reports linked to device families in our collection, 14,213 enforcement actions, and 5,292 safety communications.
FDA Database Breakdown by Category
Regulations
| Metric | Count | Description |
|---|---|---|
| Total Regulations | 2,469 | Complete FDA 21 CFR regulations for medical devices |
| Active Regulations | 2,143 | Currently active regulations with product codes |
| With Testing Matrix | 2,469 | Regulations with comprehensive testing requirements |
| With Vector Embeddings | 2,140 | Regulations with semantic search capabilities |
| Complete (≥80%) | 2,390 | High-quality, complete regulation records |
| Average Completeness | 97.18% | Overall data quality and completeness score |
Product Codes
| Device Class | Product Codes | Regulations |
|---|---|---|
| Class I | 2,011 | 774 |
| Class II | 3,119 | 75 |
| Class III | 133 | 1,392 |
| Total | 5,308 | 2,241 |
510(k) Clearances (Predicates)
| Metric | Count |
|---|---|
| Total Predicate Records | 112,219 |
| Unique K-Numbers | 69,496 |
| With Full Text Summaries | 23,395 |
| From Product Codes | 71,015 |
| From Hint Field | 41,204 |
| From Statistics | 39,515 |
Safety Data
| Data Type | Count |
|---|---|
| Product Recalls | 34,942 |
| MAUDE Adverse Events | 5,308* |
| Enforcement Actions | 14,213 |
| Safety Communications | 5,292 |
* Sample of MAUDE adverse event reports linked to device families in our collection. This represents a subset of the total MAUDE database.
Research Capabilities
This regulatory data warehouse enables advanced research across multiple domains:
- Regulatory Pathway Analysis: Study regulatory pathways across device classes, analyze classification trends, and research regulatory evolution over time
- 510(k) Predicate Device Analysis: Analyze substantial equivalence determinations, study predicate selection patterns, and research submission type distributions with 69,496 unique clearances
- Medical Device Safety Surveillance: Conduct post-market surveillance analysis, safety signal detection research, and recall pattern analysis with 34,942 recalls and 5,308 adverse events
- Standards Compliance Research: Study standards harmonization, compliance requirement analysis, and cross-standard comparison with 12,404 standard references
- Guidance Document Impact Analysis: Research guidance effectiveness, regulatory impact assessment, and guidance adoption patterns with 211 unique guidances
- Semantic Search & NLP Research: Apply natural language processing on regulatory text, semantic similarity analysis, and automated regulatory analysis with 2,140 regulations with vector embeddings
- Temporal Regulatory Analysis: Track regulatory changes, study historical regulatory evolution, and analyze effective dates with 246,801 Federal Register notices
- Cross-Reference Analysis: Study regulation-to-product code mappings, product code-to-guidance links, and multi-dimensional relationship analysis
Data Access Methods
Our regulatory dataset supports multiple access methods for researchers:
Direct MongoDB Queries
Full MongoDB query access with aggregation pipelines for analytics, indexed fields for efficient queries, and complex filtering and sorting capabilities.
RESTful API Endpoints
Structured API access with filtered queries, pagination support, and response formatting for programmatic access.
Semantic Vector Search
Vector similarity search with semantic query matching, multi-field vector search, and relevance ranking across 2,140 regulations.
Text-Based Search
Full-text search with weighted relevance, multi-field text search, synonym matching, and fuzzy matching capabilities.
Sample Access: Contact us to request a sample schema (JSON) or example query demonstrating 510(k) trend analysis. We can provide sample data exports to help you evaluate the dataset structure before full access.
Who Can Benefit from This Regulatory Dataset?
Academic Researchers
This structured regulatory dataset is ideal for:
- Regulatory Science Research: Study FDA regulatory processes, patterns, and effectiveness
- Medical Device Safety Research: Analyze post-market surveillance data and safety patterns
- Data Science Applications: Apply machine learning and NLP to regulatory text analysis
- Policy Analysis: Research regulatory policy effectiveness and impact
Universities & Research Institutions
This regulatory data warehouse provides comprehensive data for:
- Multi-Disciplinary Research: Support research across regulatory science, public health, data science, and policy
- PhD & Masters Research: Enable thesis and dissertation research with comprehensive regulatory data
- Collaborative Projects: Support multi-institution research projects with shared database access
- Longitudinal Studies: Enable temporal analysis of regulatory changes and trends
Industry Researchers
This medical device regulatory corpus supports:
- Competitive Intelligence: Analyze competitor 510(k) clearances and regulatory strategies
- Regulatory Strategy Research: Study regulatory pathways and submission patterns
- Risk Assessment: Analyze safety data for risk patterns and trends
- Standards Research: Identify applicable standards and compliance requirements
Data Quality Metrics
This regulatory dataset maintains exceptional data quality:
- Average Completeness: 97.18% - High-quality, comprehensive data records
- Complete Records (≥80%): 2,390 out of 2,469 (96.8%) - Nearly all regulations are highly complete
- Data Provenance: All data includes source tracking and timestamps for reproducibility
- Regular Updates: Dataset is regularly updated with new regulations, clearances, and safety data
- Validation Status: Field-level validation tracking ensures data accuracy
Data Currency: This regulatory dataset is continuously maintained and updated. Statistics are current as of December 2025. For the most up-to-date numbers, please contact us.
Contact Us for Research Access
Interested in accessing this regulatory dataset for research? We welcome inquiries from:
- Universities and Academic Institutions - For research, teaching, and academic projects
- Research Organizations - For regulatory science, public health, and policy research
- Collaborative Research Projects - For multi-institution research initiatives
- Individual Researchers - For PhD, Masters, and independent research
- Industry Research Teams - For regulatory intelligence and strategic research
Get Access to Our Regulatory Dataset
Contact us to discuss research access, collaboration opportunities, or questions about this structured regulatory dataset. We're committed to supporting research and advancing regulatory science.
We typically respond to research inquiries within 1-2 business days. Please include information about your research project, institution, and intended use of the database.
Frequently Asked Questions
What makes this regulatory dataset unique?
This structured regulatory corpus is one of the most comprehensive collections of FDA medical device regulatory data available. With 2,469 regulations, 69,496 510(k) clearances, 5,308 product codes, and extensive safety data—all structured, cross-referenced, and searchable—it provides researchers with unprecedented access to organized regulatory information. The dataset includes semantic search capabilities, vector embeddings, and maintains 97.18% average completeness.
Is the dataset free for academic research?
We offer various access options for academic and research institutions. Please contact us to discuss your research needs, and we'll work with you to provide appropriate access based on your project scope, institution type, and research objectives.
What data formats are available?
This regulatory dataset is accessible via MongoDB queries, RESTful API endpoints, semantic vector search, and text-based search. Data can be exported in JSON format. We can work with researchers to provide data in formats that best suit their research needs.
How often is the dataset updated?
This regulatory data warehouse is regularly updated with new regulations, 510(k) clearances, safety data, and guidance documents. We maintain data provenance and timestamps to support temporal research and reproducibility.
Can I use the dataset for commercial research?
Yes, we provide access for industry research teams and commercial organizations. Please contact us to discuss commercial research access, licensing options, and terms.
What research has been conducted using this dataset?
This medical device regulatory corpus supports research across regulatory science, medical device safety, standards compliance, policy analysis, and data science applications. We're happy to discuss potential research applications and can provide examples of research use cases upon request.
Additional Resources
Learn more about our regulatory services and capabilities:
- 510(k) Demo Project: Explore a complete, real-world FDA 510(k) submission example
- eSTAR Submission Guide: Comprehensive guide to FDA eSTAR submissions
- 510(k) Checklist Guide: Complete checklist for 510(k) submissions
- Predicate Analysis Guide: Learn about predicate device analysis
- Contact Us: Get in touch for research access or questions
Ready to Access Our Regulatory Dataset?
Contact us today to discuss research access to this comprehensive structured regulatory dataset. We're here to support your research and advance regulatory science.
Contact Us for Research Access