Before placing a medical device on the US market, manufacturers – whether US.based or foreign – must first determine how devices are classified and which premarket submission pathway applies. These steps form the foundation for compliance and market access.
How devices are classified
The FDA classifies medical devices into three categories based on risk:
- Class I – low risk
- Class II – moderate risk
- Class III – high risk
Classification depends on factors such as intended use, level of control needed to ensure safety, and effectiveness, and whether a predicate device (a comparable marketed device) exists.
Manufacturers can consult the FDA Product Classification Database, which provides classifications, regulatory citations, and associated submission requirements. For unclear cases, they may request formal feedback through the Pre-Submission process.
Understanding the main premarket pathways in the United States
The FDA offers several premarket submission pathways, depending on a device’s risk class, novelty, and availability of comparable devices on the market. Choosing the right one is essential for a smooth and successful entry into the US market.
- Exempt: many Class I and a few Class II devices are exempt from administrative approval. This means no 510(k) or other application is needed before marketing. However, manufacturers must still comply with general controls like establishment registration, device listing, labelling, and quality management system requirements.
- 510(k) Premarket Notification: this is the most common pathway for Class II devices. It requires the manufacturer to show that their product is substantially equivalent to a legally marketed device (predicate) in terms of intended use, design, and technology.
- De Novo Classification: the De Novo pathway is available for novel, low- to moderate-risk devices that have no predicate device. It allows manufacturers to request a new device classification. If granted, it can establish a new product code that others can later use for 510(k) submissions.
- Premarket Approval (PMA): PMA is intended for Class III devices for which compliance with the “general and special controls” set by the law is not sufficiently proven to ensure the safety and performance of the device.. It involves a comprehensive review of clinical and scientific data to demonstrate the device’s safety and effectiveness.
- Humanitarian Device Exemption (HDE): designed for devices that treat rare conditions (affecting or manifested in no more than 8,000 patients per year in the US), the HDE pathway allows limited marketing without proving effectiveness, provided the probable benefit outweighs the risk. It still requires FDA review and Institutional Review Board (IRB) approval at clinical sites.
Each of these pathways has distinct documentation, testing, and – in some cases –clinical data requirements. Selecting the right one early on helps reduce regulatory delays and cost.
For any questions on selling medical devices in the United States, contact us or via email to sales@obelis.net.
Georgios Mariolos
Regulatory Intelligence & Innovation
25 June 2025
References:
U.S. Food and Drug Administration. Classify Your Medical Device. Retrieved on 21/06/2025.
U.S. Food and Drug Administration. Device Approvals and Clearances. Retrieved on 21/06/2025.
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