A Complete Guide to Medical Device FDA Registration in 2026

Understanding Device Classification

Before you can register with FDA, you need to determine your device's classification. FDA categorizes medical devices into three classes based on the level of risk they pose to patients and users. Your classification determines which regulatory pathway you must follow.

Use FDA's product classification database or our Device Product Finder tool to look up the exact classification and regulatory requirements for your specific device.

Establishment Registration and Device Listing

Regardless of device class, every manufacturer, repackager, relabeler, and specification developer must register their establishment with FDA and list every commercially distributed device. This is a mandatory annual requirement.

Key Requirements

• Annual registration: Establishment registration must be renewed every year between October 1 and December 31. Late registration can result in import holds and regulatory action.
• Device listing: Every device you manufacture or distribute must be listed with FDA, including the product code, proprietary name, and other identifying details.
• DUNS number: You need a Data Universal Numbering System (DUNS) number from Dun & Bradstreet before you can register.
• US Agent (foreign facilities): Foreign device establishments must designate a US Agent who serves as the FDA communication link.

The 510(k) Premarket Notification Process

The 510(k) is the most common premarket submission pathway. It requires you to demonstrate that your device is substantially equivalent to a legally marketed predicate device. About 80% of new device clearances go through the 510(k) route.

What You Need for a 510(k)

• Predicate device identification: Find one or more legally marketed devices with the same intended use and similar technological characteristics. Our Predicate Finder tool helps streamline this search.
• Device description: Detailed description of your device including materials, design, and intended use
• Performance testing: Bench testing, biocompatibility testing, and potentially clinical data depending on the device type
• Labeling: Proposed labels, instructions for use, and any promotional materials
• Substantial equivalence comparison: A side-by-side comparison between your device and the predicate

Quality System Requirements (QSR)

FDA requires medical device manufacturers to follow the Quality System Regulation (21 CFR Part 820), which outlines current Good Manufacturing Practice (cGMP) requirements. In 2026, FDA is transitioning toward harmonizing QSR with ISO 13485.

Non-compliance with QSR is one of the top reasons FDA issues warning letters and Form 483 observations to device manufacturers. For guidance on preparing for FDA inspections, see our FDA inspection preparation guide.

UDI and Labeling Requirements

The Unique Device Identification (UDI) system is a critical component of device compliance. Most devices must carry a UDI on their label and packaging, and manufacturers must submit device information to FDA's Global Unique Device Identification Database (GUDID).

UDI Components

• Device Identifier (DI): A fixed portion that identifies the specific version or model of a device and the labeler
• Production Identifier (PI): A variable portion that includes the lot/batch number, serial number, expiration date, and manufacturing date as applicable

Use our UDI Lookup tool to search existing UDIs and verify compliance with FDA's UDI requirements. Labeling errors are among the most cited violations during FDA inspections, so getting this right from the start saves significant trouble later.

Foreign Manufacturer Requirements

Foreign device manufacturers face additional regulatory requirements when exporting to the United States. Beyond the standard registration and listing, international companies must address:

• US Agent designation: A US-based individual or company that serves as FDA's communication link. Assurentry provides US Agent services for device manufacturers starting at $399/year.
• Initial Importer listing: You must identify your Initial Importers (the US entity that first introduces your device into US commerce)
• FDA inspection readiness: FDA inspects foreign device facilities. Inspections may be announced or unannounced, and FDA has increased foreign inspection frequency in recent years.
• Import compliance: Devices are subject to review at US ports of entry. Missing or lapsed registration can result in detention and refusal.

For a comprehensive overview, visit our medical devices industry page or read our detailed 510(k) submission guide.

Step-by-Step Registration Process

Here is the complete process to register a medical device with FDA:

1. Determine your device classification using FDA's product classification database or our Device Product Finder
2. Obtain a DUNS number from Dun & Bradstreet (free, takes 1-2 business days). Use our FEI/DUNS Helper if you need assistance.
3. Designate a US Agent if you are a foreign manufacturer
4. Register your establishment through FDA's Unified Registration and Listing System (FURLS)
5. List your devices with complete product code, proprietary name, and other required information
6. Submit premarket notification (510(k), De Novo, or PMA) if required for your device class
7. Implement UDI requirements and submit device data to GUDID
8. Maintain compliance with annual registration renewal, adverse event reporting (MDR), and quality system requirements