FDA 510(k) Regulatory
Assessment & Analysis
Get comprehensive regulatory intelligence for your 510(k) submission. AI analyzes your device classification, determines regulatory pathway, identifies all testing requirements, special controls, and provides a complete compliance roadmap—all in one assessment.
What is Regulatory Assessment?
Regulatory assessment is a comprehensive analysis that determines your device's regulatory pathway, identifies all compliance requirements, testing needs, and special controls. It's your complete roadmap to FDA clearance.
Regulatory Pathway
Determines whether your device requires Traditional 510(k), Special 510(k), Abbreviated 510(k), De Novo, or PMA pathway based on classification and device characteristics.
Testing Requirements
Identifies all required testing: biocompatibility (ISO 10993), electrical safety (IEC 60601), software lifecycle (IEC 62304), cybersecurity, human factors, and clinical evidence needs.
Special Controls
Identifies applicable special controls, recognized standards, FDA guidance documents, and labeling requirements specific to your device classification.
How Comprehensive Regulatory Assessment Works
Our AI-powered assessment analyzes every aspect of your device to provide complete regulatory intelligence and compliance roadmap.
Classification Analysis
Uses your confirmed device classification (product code, regulation, device class) as the foundation for all regulatory analysis. Ensures assessment is based on accurate classification.
Pathway Determination
Analyzes device characteristics, classification, and precedent to determine the appropriate regulatory pathway: Traditional/Special/Abbreviated 510(k), De Novo, or PMA.
Guidance & Standards Retrieval
Retrieves all applicable FDA guidance documents, recognized consensus standards, and special control guidance specific to your product code and device characteristics.
Testing Requirements Analysis
Identifies all required testing based on device characteristics: biocompatibility (if patient contact), electrical safety (if electrical), software documentation (if has software), cybersecurity (if connected), human factors (if user interface), and clinical evidence needs.
Special Controls Mapping
Maps all special controls applicable to your product code, identifies related guidance documents and standards, and creates a task list for each control requirement.
Compliance Roadmap Generation
Generates a comprehensive compliance roadmap with prioritized tasks, timeline estimates, testing requirements checklist, and documentation needs organized by submission section.
Why Use AI Regulatory Assessment?
Traditional regulatory assessment requires weeks of research and deep FDA expertise. AI assessment delivers comprehensive intelligence in 15-45 minutes.
15-45 Minutes, Not Weeks
Complete regulatory assessment with pathway analysis, testing requirements, special controls, and compliance roadmap in 15-45 minutes instead of weeks of research.
Comprehensive Coverage
Analyzes all regulatory dimensions: pathway, testing, special controls, guidance documents, standards, labeling, and cybersecurity requirements in one assessment.
Prioritized Roadmap
Provides prioritized compliance roadmap with task lists, timeline estimates, and dependencies. Know exactly what needs to be done and in what order.
Guidance Document Retrieval
Automatically retrieves and cites all applicable FDA guidance documents, special control guidance, and recognized consensus standards relevant to your device.
Cybersecurity Requirements
Identifies cybersecurity requirements for devices with software or connectivity, including threat modeling, SBOM, patching policy, and security testing needs.
Risk Identification
Identifies potential regulatory risks, gaps in required documentation, and areas that may require FDA pre-submission meetings (Q-Sub) before proceeding.
Complete Assessment Package
Get comprehensive regulatory intelligence covering every aspect of your 510(k) submission requirements.
Regulatory Pathway Analysis
Clear determination of submission pathway (Traditional/Special/Abbreviated 510(k), De Novo, or PMA) with rationale and complexity assessment.
Testing Requirements Matrix
Complete list of required testing organized by category: bench testing, biocompatibility, electrical safety, software, cybersecurity, human factors, and clinical.
Special Controls Identification
All applicable special controls with related guidance documents, recognized standards, and specific compliance tasks.
FDA Guidance Retrieval
Retrieves and cites all applicable FDA guidance documents, special control guidance, and industry standards relevant to your device classification.
Labeling Requirements
Identifies labeling requirements including UDI requirements, GUDID registration needs, and specific labeling guidance for your device type.
Compliance Roadmap
Prioritized task list with timeline estimates, dependencies, and submission milestones. Clear path from assessment to submission-ready package.
Frequently Asked Questions
Common questions about regulatory assessment and pathway analysis.
What information does regulatory assessment provide?
Regulatory assessment provides: (1) Regulatory pathway determination (510(k) type, De Novo, or PMA), (2) Complete testing requirements matrix organized by category, (3) Special controls identification with related guidance, (4) Applicable FDA guidance documents and standards, (5) Labeling and UDI requirements, (6) Cybersecurity requirements (if applicable), (7) Prioritized compliance roadmap with timeline estimates.
How accurate is AI regulatory assessment?
AI regulatory assessment achieves high accuracy by analyzing your confirmed device classification against comprehensive FDA databases, guidance documents, and precedent. Results are based on official FDA regulations and guidance. However, for novel devices or complex scenarios, we recommend confirming pathway with FDA Pre-Submission (Q-Sub) meetings.
What's the difference between regulatory assessment and classification?
Classification identifies your device's regulatory class (I/II/III), product code, and regulation. Regulatory assessment uses that classification to determine submission pathway, identify all testing requirements, special controls, and create a complete compliance roadmap. Assessment is the next step after classification.
Does assessment identify cybersecurity requirements?
Yes. If your device contains software or has connectivity (wireless, Bluetooth, WiFi, etc.), the assessment automatically identifies cybersecurity requirements including threat modeling, Software Bill of Materials (SBOM), patching policy, and security testing needs per FDA SaMD guidance.
How long does regulatory assessment take?
AI-powered regulatory assessment typically completes in 15-45 minutes. The system analyzes classification, retrieves guidance documents, identifies requirements, and generates comprehensive roadmap. Traditional manual assessment can take weeks of regulatory affairs expert research.
Can I use assessment results for FDA submissions?
Yes. Assessment results are based on official FDA regulations, guidance documents, and recognized standards. The testing requirements, special controls, and compliance roadmap provide the foundation for your 510(k) submission strategy. However, final pathway determination for novel devices should be confirmed through FDA Q-Sub meetings.