US FDA Medical Device Classification and Determination: A Step-by-Step Overview

Navigating the FDA medical device classification process is critical for manufacturers looking to enter the US market successfully. Understanding how the FDA classifies devices impacts your regulatory submission, approval timeline, and overall market strategy. 

In this article, we provide a clear, 3-step guide to help you understand the FDA medical device classification and determination process, complete with essential resources and regulatory insights. 

 

Step 1: Clarify Your Product’s Intended Use and Regulatory Category 

The first step is to determine how the FDA classifies your product based on its intended use and claims. This classification determines which FDA regulations apply to you: 

• Medical Device — Defined under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 

• Drug — Section 201(g) of the FD&C Act 

• Cosmetic — Section 201(i) of the FD&C Act 

• Biologic — Under Section 351 of the Public Health Service Act (PHS Act) 

Understanding this distinction is essential to avoid misclassification and ensure compliance. 

 

 

Step 2: Locate Your FDA Product Code and Regulatory Pathway 

Next, identify the FDA product code that corresponds to your device. This will help define the specific regulatory requirements and pathways applicable. 

Useful FDA Resources Include: 

• FDA Product Classification Database 

• Code of Federal Regulations (CFR) Title 21 

• FDA 510(k) Premarket Notification Database 

• Premarket Approval (PMA) Database 

• De Novo Classification Database 

• FDA Establishment Registration & Device Listings 

Checking competitor devices and their clearance routes can provide useful benchmarks for your own classification and submission planning. 

 

Step 3: Request FDA Device Classification Determination 

If the classification is unclear or you need official FDA feedback, you can request a determination via two methods: 

Informal Device Determination 

• Send a query email to: DeviceDetermination@fda.hhs.gov 

• No user fees apply 

• Usually responded to within 15 calendar days 

Formal 513(g) Determination Request 

• Used for complex classification questions 

• Requires payment of the FDA user fee (FY2024 fee: $6,528) 

• Submit the request with FDA Form 3601 and supporting documents 

• Submission through FDA’s eStar system (optional but recommended) 

• FDA responds within approximately 60 calendar days 

• Official letter issued detailing classification and regulatory pathway or enforcement discretion status 

 

Additional FDA Regulatory Pathways to Consider 

Based on classification, your device might be subject to different submission requirements: 

• Exempt – No premarket submission needed 

• 510(k) – Premarket notification demonstrating substantial equivalence 

• PMA – Premarket approval for high-risk devices 

• De Novo – For novel devices of moderate risk without a predicate 

• HUD (Humanitarian Use Device) 

• EUA (Emergency Use Authorization) 

• BLA (Biologics License Application), NDA (New Drug Application), IDE (Investigational Device Exemption) for clinical investigations 

For combination products (e.g., drug-device), a Request for Designation (RFD) may be required. 

 

Partner with BioBoston Consulting for Seamless FDA Submission 

Successfully navigating FDA medical device classification and regulatory pathways can be complex and time-consuming. BioBoston Consulting specializes in providing expert regulatory consulting, FDA submission assistance, and strategic guidance tailored to your device and business needs. 

Whether you require support with: 

• FDA device classification and determination requests 

• Preparing and submitting 510(k), PMA, or De Novo applications 

• Conducting FDA Q-Sub meetings 

• Developing comprehensive regulatory strategies 

BioBoston Consulting is your trusted partner to accelerate time-to-market and ensure FDA compliance. 

 

Conclusion: Simplify Your FDA Medical Device Classification Journey Today 

Proper classification is the cornerstone of your device’s regulatory success. From clarifying your product’s intended use to engaging FDA through formal determination requests, understanding these steps helps streamline approvals and mitigate risks. 

Contact BioBoston Consulting today for personalized FDA regulatory consulting and submission support. Let our experienced team guide you through every phase of FDA medical device classification and help you achieve confident, compliant market entry.