Understanding FDA Medical Device Classes and Why They Matter

By Henry Duah

Innovation in healthcare technology depends not only on developing breakthrough devices but also on navigating regulatory pathways that ensure these devices are safe and effective. The U.S. Food and Drug Administration (FDA) plays a crucial role in protecting patient safety by classifying medical devices into three distinct classes based on their level of risk. These classes determine the regulatory requirements for bringing a device to market, which in turn affect development time, costs and the intensity of oversight. 

In this innovation snapshot, we explore the various classes for medical devices and the process by which they are classified.

What Are FDA Medical Device Classes?

First, we need to understand how medical devices are defined. A medical device, broadly defined, includes any instrument, apparatus, implant, or software intended for medical use. This portfolio ranges from simple, non-invasive tools, such as tongue depressors and bandages, to complex devices, including pacemakers and surgical robots. Even some software applications, depending on their function, are regulated as medical devices.

The FDA’s Center for Devices and Radiological Health (CDRH) categorises all medical devices marketed in the United States into three classes: Class I, Class II, and Class III. Each class corresponds to the device’s risk level to patients and the regulatory controls required to ensure safety and effectiveness. As the class number increases, so does the complexity of regulations and the device’s potential risk.

Why Device Classification Matters

Understanding medical devices’ classification early in development is crucial because it shapes the entire regulatory pathway:

• Determines whether a premarket submission to the FDA is required, and the type of submission.
• Guides the level of clinical data and testing necessary.
• Influences time to market and associated costs.
• Ensures compliance with quality and post-market surveillance standards.

The Three FDA Medical Device Classes

1. Class I: Low Risk Devices

Devices in this class are simple and pose minimal potential harm to patients. They typically do not support or sustain life, nor are they critical in preventing health impairment. General FDA controls apply, mostly involving quality system regulations and proper labelling, with most Class I devices exempt from rigorous premarket submissions. Bringing Class I devices to market is generally faster and less costly due to fewer regulatory hurdles.

Examples include: tongue depressors, bandages, hospital beds and electric toothbrushes.

2. Class II: Moderate Risk Devices

These devices carry a higher risk than Class I and often come into sustained contact with the patient or play a more direct role in diagnosis or treatment. In addition to general controls, Class II devices require “special controls,” such as performance standards, postmarket surveillance, and specific labelling. The majority of devices in this category require premarket notification through the FDA’s 510(k) pathway, where the manufacturer demonstrates that the device is substantially equivalent to an existing legally marketed device (predicate).

Examples include: catheters, blood pressure cuffs, syringes, contact lenses and surgical gloves.

3. Class III: High Risk Devices

Class III devices usually sustain or support life, are implanted, or have a significant risk of illness or injury. Due to their critical function, these devices undergo the most stringent regulatory controls, including the Premarket Approval (PMA) process, which demands robust clinical evidence demonstrating safety and effectiveness. The PMA process involves substantial clinical trials and a thorough FDA review of device quality systems and manufacturing processes, often extending time and cost to market.

Examples include: high-frequency ventilators, pacemakers, breast implants and implanted prosthetics.

How Devices Are Classified

To classify a device, manufacturers first identify the medical speciality among the 16 specialities  (e.g., cardiovascular, orthopaedic) according to FDA regulations and then locate the device type within that category. The FDA has classified approximately 1,700 device types grouped under the 16 medical specialities.

If an innovative device lacks a predicate or equivalent in FDA records, it is generally assigned to Class III owing to the unknown risk profile, triggering the PMA process.

Why Innovators and the General Public Should Care.

Early understanding of device classification empowers startups and developers to:

• Select appropriate regulatory strategies.
• Design efficient development and testing plans.
• Anticipate market entry challenges and timelines.
• Communicate effectively with FDA reviewers.

FDA medical device classes form the foundational framework for ensuring healthcare innovations reach patients safely and effectively. This framework strikes a balance between the need for innovation and thorough oversight, enabling safe and effective devices to reach the market while protecting patients from harm.

The general public benefits from this system because it ensures that medical devices are thoroughly evaluated and regulated according to their potential impact on health, thereby fostering trust, transparency, and improved treatment outcomes.

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