Need Regulatory Help? Try Our Platform
Post your regulatory questions or request quotations from verified pharmaceutical consultants worldwide. Get matched with experts who specialize in your market.
February 2, 2025
Approximately 5 minutes
US FDA Medical Device Classification: Risk-Based System and Pathways for Novel Devices
US FDA Medical Device Classification: Risk-Based System
The U.S. Food and Drug Administration (FDA) classifies medical devices into one of three classes (Class I, II, or III) based on the increasing risk they pose to the patient or user. Unlike the rules-based systems used in Europe, the FDA uses a predicate-based system where classification is often determined by finding a legally marketed device that is Substantially Equivalent (SE) to the new product.
🏥 The Three Device Classes
| Class | Risk Level | Required Controls | Premarket Submission | Example |
|---|---|---|---|---|
| Class I | Low Risk | General Controls | Usually Exempt | Adhesive Bandages |
| Class II | Medium Risk | Special Controls | 510(k) Notification (often) | Endoscopes, Powered Wheelchairs |
| Class III | High Risk | General + Special Controls | Premarket Approval (PMA) | Pacemakers, Heart Valves |
1. Class I (Low Risk) These devices are typically simple in design, such as scalpels and manual stethoscopes. Compliance is primarily ensured through General Controls (e.g., proper manufacturing, labeling, and facility registration). Most Class I devices are exempt from premarket clearance.
2. Class II (Medium Risk) These devices are more complex, but their failure is unlikely to cause serious injury immediately. Special Controls (e.g., performance standards, post-market surveillance) are required in addition to General Controls. Many Class II devices require a 510(k) Pre-market Notification to demonstrate Substantial Equivalence to a predicate device.
3. Class III (High Risk) These devices support or sustain human life, are of substantial importance in preventing health impairment, or pose a potentially unreasonable risk of illness or injury. They require the most rigorous review: Premarket Approval (PMA), which demands extensive scientific data, including clinical trial results, to prove safety and efficacy.
🔎 Classifying Novel Devices (De Novo and 513(g))
Determining Classification Most devices can be classified by searching the FDA classification database for a Substantially Equivalent predicate device. This search reveals the device's classification, the three-letter Product Code, and the specific regulation number.
513(g) Request for Information If no clear predicate device can be identified, manufacturers can submit a 513(g) Request for Information to the FDA. The agency will evaluate the information and issue a ruling on the device's classification within 60 days. This submission does not grant market approval.
De Novo Classification Request Devices that are entirely new and have no existing classification are automatically considered Class III. If the manufacturer believes the device is not high risk, they may file a De Novo classification request to reclassify it as Class I or Class II. Upon successful De Novo approval, the device can be marketed immediately and serves as a new predicate for future devices.
Ask Anything
We'll follow up with you personally.
Related Articles
Approximately 5 minutes
US FDA Establishment Registration and Device Listing (FURLS) Requirements
Annual **Establishment Registration** and **Device Listing** with the US FDA is mandatory for most facilities involved in manufacturing, importing, or reprocessing devices for the US market. Registration is completed via the online **FURLS** system, and listing is generally required unless the entity is an Initial Importer.
Approximately 5 minutes
US FDA Clearance Pathways: Classification, QSR, and the 510(k) / PMA Process
All medical and IVD devices for sale in the US must follow the FDA's regulatory process, which involves risk-based classification (Class I, II, III), compliance with the Quality System Regulation (QSR), and securing premarket authorization through 510(k) or Premarket Approval (PMA).
Approximately 5 minutes
Understanding the FDA Q-Submission (Q-Sub) Process and Pre-Submission Guidance
The FDA's Q-Submission (Q-Sub) process, primarily used as a **Pre-Submission (Pre-Sub)**, allows medical device manufacturers to receive formal, non-mandatory regulatory feedback from FDA experts *before* submitting their 510(k), PMA, or IDE application. This early dialogue is crucial for novel or high-risk devices.
Approximately 5 minutes
How Long is the FDA Review Process for 510(k) Medical Device Submissions? (MDUFA III Goals)
The FDA's goal, per MDUFA III, is to issue a final clearance decision for most 510(k) submissions within **90 calendar days**. Key milestones include acceptance review within 15 days and substantive review decisions within 60 days, providing manufacturers with a predictable communication timeline.
Approximately 5 minutes
US Medical Device Clearance: The Predicate Pathway and FDA's Regulatory Philosophy
The US FDA emphasizes different regulatory barriers than the EU. The **510(k) pathway** often allows clearance based on demonstrating **substantial equivalence** to a predicate device, representing a distinct philosophy focused on comparative safety and effectiveness rather than the continuous, stricter clinical evaluation required by the EU MDR.
Approximately 5 minutes
Technical Overview: The FDA ANDA Process for Generic Drug Approval
The Abbreviated New Drug Application (ANDA) is the FDA pathway (Section 505(j)) for generic drug approval, requiring demonstration of **pharmaceutical equivalence** and **bioequivalence (BE)** to a Reference Listed Drug (RLD). The process involves RLD identification, Q1/Q2 formulation, BE studies, stability testing, and eCTD submission under GDUFA.