Navigating FDA Compliance Together

Foreign medical device manufacturers must designate a U.S. Agent with the FDA as a condition of registration. We serve as your official U.S. representative managing FDA communications, coordinating inspections, and supporting your annual renewal requirements.

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Medical Device Establishment Registration

Manufacturers, importers, and distributors of medical devices sold in the U.S

Initial Device Establishment Registration
510(k) & PMA Coordination
Annual Renewal
Registration Amendments

Medical Device Listing

In addition to establishment registration, all medical devices marketed in the U.S.

Device Listing Submission (FURLS)
IVD Device Listing
Annual Device Listing Updates
UDI (Unique Device Identifier) Support

Structured Product Labeling (SPL) Medical Devices

FDA food labeling regulations under 21 CFR Parts 101 190 are detailed.

Device Listing SPL Submission
Device Labeling SPL
SPL Updates & Amendments
UDI & GUDID SPL Integration

Medical Device Label Review

FDA medical device labeling requirements under 21 CFR Part 801 are extensive

Device Label Compliance Review
UDI Label Review
Instructions for Use (IFU) Review
Import Device Label Review

Tobacco Product Registration

In addition to establishment registration, all medical devices marketed in the U.S.

Tobacco Establishment Registration
Tobacco Product Listing
Harmful & Potentially Harmful Constituents (HPHCs)
U.S. Agent for Tobacco Manufacturers

Medical Device Registration Renewals

Medical device establishment registrations must be renewed annually between October.

Annual Device Establishment Renewal
Annual Device Listing Updates
U.S. Agent Annual Renewal
Registration Amendments

Why Choose FDA Entry?

Fast Turnaround: Most registrations completed within 24 to 48 hours. We understand time-to-market matters.
Expert Team: Regulatory specialists with decades of combined FDA experience at your service.
Transparent Pricing: Clear, upfront pricing with no hidden fees. Know exactly what you’re paying for.
Secure & Confidential: Your proprietary information is protected with enterprise-grade security protocols.

READY TO ENSURE YOUR FDA COMPLIANCE?

Let’s discuss how we can support your food or beverage business. Get a free consultation today.