FDA Establishment Registration & Device Listing — Done for You in 3 Steps

Step 1

Classify Your Device

FDA medical device registration starts with the right product code. We identify your device's FDA class (I, II, or III), the specific product code from FDA's classification database, and whether your device qualifies as 510(k) exempt. Getting this step right determines everything that follows — the wrong product code can mean a 510(k) clearance requirement you didn't know about, or a clearance you skipped that you actually needed.

If your device's classification is genuinely uncertain — because the intended use is novel, the technology crosses device categories, or the device-drug-combination product line is unclear — we file a 513(g) Request for Classification to obtain FDA's written determination before committing to a development program or investment. A 513(g) response from FDA is the most reliable classification anchor you can have going into registration.

Covered: FDA product code identification · Class I / II / III determination · 510(k) exempt status analysis · 513(g) filing when classification is ambiguous · Regulatory class documentation for audit readiness

Step 2

Clear Your Submission (if required)

510(k) exempt devices skip this step entirely — once classified, they can proceed directly to FDA registration and listing. For Class II devices that are not exempt, we manage your 510(k) submission: predicate device selection, substantial equivalence argument, performance testing planning, and eSTAR package compilation through FDA clearance.

For novel devices without a predicate — where De Novo is the applicable pathway — we build the De Novo classification request: device description, proposed special controls, risk analysis, and Pre-Submission meeting strategy to maximize FDA acceptance. For Class III devices, we develop the PMA strategy aligned to the specific review division and the device's clinical evidence base.

If your device is 510(k) exempt, we document the exemption basis so your registration file is audit-ready and import-defensible from day one.

Covered: 510(k) exempt documentation · 510(k) submission management · De Novo classification request · PMA strategy for Class III devices · Predicate selection and substantial equivalence analysis

Step 3

Register & List with FDA

With classification confirmed and any required clearance in hand, we complete your FDA establishment registration in FURLS (FDA's Unified Registration and Listing System): account setup, establishment information, annual registration fee payment, and device listing with all required product codes and submission numbers. Annual renewal management is included — we track the October 1 – December 31 renewal window and handle the submission so your registration never lapses.

Device listings are updated within FDA's 30-day requirement whenever your product portfolio changes: new products added to commercial distribution, discontinued products delisted, or significant changes that affect the product code or submission status. A complete, current, accurate device listing is the difference between clean US market access and an import detention or FDA inspection finding.

Covered: FURLS account creation and setup · Establishment registration submission · Device listing with product codes · Annual renewal management · Listing updates for new products, changes, and discontinuations · Foreign establishment registration with US Agent designation