Tools

Tools for Medical Device Professionals

Purpose-built tools for regulatory affairs and quality professionals. Search FDA databases, find predicate devices, navigate pathways, and more.

Coming Soon

FDA Product Code Lookup

Search and explore FDA product classification codes. Find the right product code, regulation number, and submission type.

Regulatory510(k)

Coming Soon

MAUDE Database Explorer

Search FDA's adverse event database with a modern interface. Analyze trends and export reports.

RegulatoryPost-Market Surveillance

Planned

510(k) Predicate Finder

Find potential predicate devices for your 510(k) submission by product code, device name, or applicant.

Regulatory510(k)

Planned

Regulatory Pathway Navigator

Interactive decision tree to determine the right regulatory pathway across FDA, EU, and other markets.

RegulatoryEU MDR / IVDR

Planned

Standards Tracker

Track relevant ISO/IEC standards for your device type. Get notified of updates and new editions.

Standards & Testing

Planned

UDI Format Helper

Generate and validate UDI strings in GS1 and HIBCC formats.

Labeling & UDI