FDA Compliance <span class="bg-gradient-to-r from-blue-400 to-cyan-400 bg-clip-text text-transparent">Tools

Product Code Lookup

Search FDA product classification database by name, code, or category.

Database

Import Alert Checker

Check if manufacturers or products are on the FDA Red List (DWPE).

510(k) Predicate Finder

Find cleared predicate devices for your 510(k) submission.

Device Product Code Finder

Search medical device product codes with semantic and text search.

Database

UDI/GUDID Validator

Validate UDI strings and search the Global UDI Database.

Import Product Codes

Browse FDA import product code hierarchy by industry, class, and subclass.

Database

Drug NDC & SPL Validator

Validate NDC numbers and look up drug listings in the NDC Directory.

Warning Letter Search

Search and analyze FDA warning letter patterns and enforcement trends.

Registration Status Check

Check FDA facility registration and compliance standing.

FEI/DUNS Helper

Look up Facility Establishment Identifiers and DUNS numbers.

Ingredient Checker

AI-powered analysis of ingredient lists for FDA compliance issues.

AI-Powered

Label Reviewer

Upload product packaging artwork for AI-powered compliance review.

AI-Powered

Compliance Calculator

Answer 2 questions to find your FDA requirements, timelines, and fees.

FDA Fee Calculator

Calculate FDA user fees and compare costs vs competitors.

Deadline Calculator

Calculate FDA submission timelines, Prior Notice windows, and renewal periods.

ROI Calculator

Calculate the cost savings of using Assurentry vs traditional methods.

Country Requirements Finder

Find FDA requirements by country and product category for foreign facilities.

Requirement Checker

Determine if you need FDA registration, a US Agent, or other requirements.

Renewal Checker

Check biennial and annual FDA renewal deadlines for your registrations.

Registration Verifier

Verify FDA registration status for your establishment.

MoCRA Readiness Checker

Assess your cosmetics company's readiness for MoCRA compliance.

MoCRA Product Validator

Scan INCI ingredient lists against FDA VCRP restricted substance database.

US Agent Switch Readiness

Assess the complexity and timeline for switching your FDA US Agent.

Export Certificate Readiness

Check your readiness for FDA export certificates.

Compliance Checklist

Generate a compliance checklist by product type with progress tracking.

Letter Builder

Build FDA-compliant response letters for warning letters and detentions.

Detention Response Builder

Build responses to FDA import detentions with regulatory citations.

Prior Notice Prep

Prepare Prior Notice filings for food imports with all required data fields.

US Agent Wizard

Step-by-step guide through the FDA US Agent designation process.

Barcode Builder

Generate barcodes for product packaging in multiple formats.

Requirement Matrix

Cross-product type requirement comparison for multi-category companies.

Food Safety Plan Builder

Build a HARPC-compliant food safety plan with hazard analysis, preventive controls, and monitoring procedures.

FSMA Compliance Scorecard

Assess your facility's FSMA compliance across preventive controls, FSVP, produce safety, recordkeeping, and training.