How does the FDA classify medical devices?

The FDA classifies devices based on risk: • Class I (Low Risk): Subject to general controls (e.g., surgical gloves, tongue depressors) • Class II (Moderate Risk): Require general and special controls (e.g., infusion pumps, pregnancy test kits) • Class III (High Risk): Require Premarket Approval (PMA) due to potential life-sustaining uses (e.g., pacemakers, breast implants)

What is a 510(k) submission?

A 510(k) Premarket Notification demonstrates that a Class II device is substantially equivalent to an already legally marketed device. It is required before commercial distribution in the U.S.

What is the difference between device registration and listing?

• Registration: Identifies the facility (manufacturer, importer, etc.) with the FDA. • Listing: Identifies the specific devices being marketed by the registered facility. Both are required annually.

What happens if my device is misclassified?

• The FDA may delay or deny market access. • You may incur additional testing or submission requirements. • Our classification assessments ensure correct initial submissions, saving time and costs.

What is UDI, and why is it required?

The Unique Device Identification (UDI) system: • Identifies devices through distribution and use. • Helps with post-market surveillance and recall management. • We assist with UDI assignment and FDA GUDID submissions.

Do foreign manufacturers need a U.S. Agent?

Yes. Foreign medical device manufacturers must appoint a U.S. Agent for: • FDA communications and submissions • Emergency contact during compliance reviews • We provide U.S. Agent services for seamless U.S. market access.

Medical Device Classification & FDA Listing

Overview

Service overview

We confirm your device class and product code, identify the right regulatory pathway, and manage your FDA device listings and annual renewals.

Product documentation being reviewed for compliance

Why this service matters

The FDA classifies medical devices by risk, which sets the regulatory requirements.
Classification determines whether you need a 510(k), PMA or an exemption.
Errors can lead to import detentions, warning letters and market delays.

FDA Medical Device Classification Assessment

We help you determine your device's class (I, II or III) based on intended use, risk profile and FDA requirements.

Device classification analysis (Class I, II, or III)
Product code identification for accurate FDA submissions
Regulatory pathway determination (510(k), PMA, De Novo)

Cargo containers moving through an international port — Medical Devices & Cosmetics
Medical Device Listing & Classification Support

FDA Medical Device Listing Services

Devices sold in the US must be listed with the FDA under the manufacturer's or importer's establishment registration, and we manage listings and annual renewals.

Initial device listing submissions to the FDA FURLS system
US Agent services for foreign manufacturers
Annual renewal submissions to maintain active status

510(k) Premarket Notification Support

Most Class II devices need a 510(k) Premarket Notification showing substantial equivalence to a legally marketed device, and we guide you through it.

Preparation and submission of 510(k) applications
Substantial equivalence analysis and predicate device identification
Technical documentation reviews and performance testing summaries

Premarket Approval (PMA) Consultation & Support

Class III devices, which carry the highest risk, typically need Premarket Approval (PMA), and we provide strategic support through the submission.

Clinical trial design support and data collection strategies
Preparation of PMA applications and supporting documentation
Risk management and safety validation reviews

Exemption & Special Controls Assessment

Some Class I and Class II devices are exempt from certain regulatory controls, and we assess whether your device qualifies.

Identification of potential exemptions from 510(k) requirements
Review of special controls applicable to specific device categories
Documentation support for exemption justifications

Labelling & UDI (Unique Device Identification) Compliance

Compliant labelling and Unique Device Identification (UDI) are critical for device traceability and post-market safety, and we review both.

Label review and compliance checks per FDA guidelines
Risk labelling for high-risk devices per FDA specifications
Country of origin and manufacturer details inclusion

Ongoing compliance support

Time-Saving
We handle classification research and FURLS listing submissions for you.
Regulatory Assurance
Accurate classification and product codes support the right submissions under 21 CFR Part 807.
Peace of Mind
Reduce the risk of import holds, warning letters and delays to market entry.

What you'll need

Classification drives everything else, so describe your device clearly.

Device descriptionEnough detail to set Class I, II or III.
Product codeOr the information needed to identify it.
A US AgentRequired for foreign manufacturers listing devices.
Current labelsFor checks against FDA labelling guidance.

Medical Device Listing & Classification Support