What are examples of Class 1 2 and 3 medical devices?

September 28, 2025 •

4 min read

According to the U.S. Food and Drug Administration (FDA), medical devices are categorized into three classes based on their potential risk to patients and users. Understanding these classifications is crucial for both healthcare professionals and consumers, as it defines the regulatory controls required for safety and effectiveness and answers the question: what are examples of Class 1, 2, and 3 medical devices?

Quick Summary

Examples of medical devices across Class 1, 2, and 3 include low-risk items like bandages and tongue depressors, moderate-risk devices such as infusion pumps and pregnancy test kits, and high-risk, life-sustaining equipment like pacemakers and implantable heart valves.

Key Points

Low-Risk Devices (Class 1): Simple, well-understood devices like bandages, examination gloves, and manual wheelchairs fall under this category, requiring the least regulatory oversight.
Moderate-Risk Devices (Class 2): This class includes devices like CT scanners, infusion pumps, and blood pressure monitors that require both general and special controls to ensure safety and performance.
High-Risk Devices (Class 3): Pacemakers, heart valves, and other life-sustaining devices with potential for significant harm are designated Class 3 and undergo the most stringent regulatory review.
FDA Oversight: The U.S. Food and Drug Administration (FDA) is responsible for this three-tiered classification system, which governs the premarket review and ongoing surveillance of medical devices.
Regulatory Pathway: The classification of a medical device dictates its path to market, from the necessary documentation and testing to the required FDA submission (e.g., 510(k) or PMA).
Patient Safety Prioritized: The primary purpose of this classification system is to balance innovation with public health, ensuring that the level of regulatory control is proportional to the potential risk posed to patients.

Understanding the FDA's Medical Device Classification System

The FDA's three-tiered classification system—Class 1, 2, and 3—is a risk-based framework designed to ensure the safety and effectiveness of medical devices marketed in the U.S. This hierarchy establishes the level of regulatory scrutiny each device must undergo before it can be legally sold and distributed. The rigor of this oversight is directly proportional to the risk the device poses to the patient or user. The classification of a device is determined by its intended use and indications for use.

In-Depth Look at Class 1 Medical Devices

Class 1 devices represent the lowest risk category and are subject to the least amount of regulatory control. These devices are typically simple in design and have a proven track record of safety. The regulatory controls applied to Class 1 devices are known as "General Controls," and they include requirements for proper registration and listing, good manufacturing practices (GMP), accurate labeling, and adverse event reporting. Many Class 1 devices are also exempt from the premarket notification process, also known as 510(k) clearance, which is required for higher-risk devices.

Examples of Class 1 devices include:

Elastic bandages: Used for basic wound support and compression.
Tongue depressors: Simple tools for oral examinations.
Examination gloves: Provides a protective barrier for both the patient and healthcare provider.
Handheld surgical instruments (non-electric): Basic tools like scalpels and surgical scissors.
Manual wheelchairs: Designed for mobility assistance without electrical components.
Stethoscopes: Used for listening to internal body sounds, such as heart and lung sounds.

Exploring Class 2 Medical Devices

Moving up the risk scale, Class 2 devices pose a moderate risk to patients and require more stringent controls than Class 1. In addition to General Controls, Class 2 devices are subject to "Special Controls." These controls vary depending on the specific device but can include performance standards, postmarket surveillance, and special labeling requirements. The majority of Class 2 devices must undergo a premarket notification (510(k)) process, where the manufacturer must demonstrate that their new device is "substantially equivalent" to an existing, legally marketed device (a "predicate" device).

Examples of Class 2 devices include:

Infusion pumps: Devices that deliver controlled amounts of fluids, such as nutrients or medications, to a patient.
CT scanners and MRI machines: Diagnostic imaging systems that require special controls for accuracy and safety.
Blood pressure monitors: Used for measuring and tracking a patient's blood pressure.
Pregnancy test kits: In-vitro diagnostic (IVD) devices that have specific performance criteria.
Powered wheelchairs: Unlike manual versions, these require specific performance standards related to their electrical and mechanical components.
Surgical needles and catheters: These tools carry a higher risk of complications and therefore require stricter controls.

The Highest Risk: Class 3 Medical Devices

Class 3 is the highest risk category, reserved for devices that are life-sustaining, life-supporting, or have the potential for serious harm if they fail. These devices are subject to the most rigorous regulatory requirements. All Class 3 devices require a premarket approval (PMA) application, a comprehensive scientific and regulatory review process that demands extensive clinical evidence to demonstrate the device's safety and effectiveness. This process is the most time-consuming and expensive for manufacturers, reflecting the high stakes involved with these critical devices.

Examples of Class 3 devices include:

Pacemakers: Implantable devices that regulate a patient's heart rhythm.
Implantable heart valves: Artificial valves used to replace diseased or damaged heart valves.
Ventricular assist devices (VADs): Mechanical circulatory support devices used to support heart function.
Breast implants: Devices with high-risk profiles that require extensive clinical evidence.
Defibrillators: Devices used to deliver an electric shock to the heart in cases of life-threatening arrhythmias.
Cochlear implants: Electronic devices that provide a sense of sound to a person with severe hearing loss.

Comparison of Medical Device Classes


Feature	Class 1	Class 2	Class 3
Risk Level	Low	Moderate	High
Regulatory Controls	General Controls (Registration, GMP, Labeling)	General Controls + Special Controls (Performance standards, Postmarket Surveillance)	General Controls + Premarket Approval (PMA)
Premarket Review	Most are exempt from 510(k)	Most require 510(k) clearance	Requires full Premarket Approval (PMA)
Market Entry	Can enter the market with minimal regulatory review	Requires demonstration of substantial equivalence	Requires extensive clinical data and rigorous review
Examples	Bandages, gloves, tongue depressors, manual wheelchairs	Infusion pumps, CT scanners, blood pressure cuffs, powered wheelchairs	Pacemakers, heart valves, breast implants, defibrillators

How FDA Classification Impacts Development and Marketing

For a medical device manufacturer, correctly classifying a device is the foundational step in the entire development process. The classification determines the entire regulatory pathway, from the necessary design controls and testing protocols to the type of marketing application required by the FDA. A Class 1 device, for instance, has a much faster and less expensive route to market than a Class 3 device. This impacts everything from the timeline for product development and launch to the overall investment required. For consumers, understanding these classes offers a degree of transparency, highlighting the level of regulatory oversight applied to the devices they rely on for their health. An authoritative resource for more information on the FDA's regulatory processes can be found on the FDA website.

The Importance of Ongoing Vigilance

It's important to remember that even after a device is cleared or approved, the FDA continues its oversight through postmarket surveillance. Manufacturers are required to report adverse events, and the FDA monitors these reports to identify potential safety issues with medical devices. This is especially critical for Class 2 and 3 devices. Additionally, new technologies and uses can sometimes lead to a reclassification of a device. The dynamic nature of the healthcare industry means that the regulatory landscape is constantly evolving to keep pace with innovation and ensure patient safety remains the highest priority.

Frequently Asked Questions

The main difference lies in the level of risk and regulatory control. Class 1 devices are low-risk and require only general controls, while Class 2 devices are moderate-risk and require both general controls and specific special controls, often necessitating a 510(k) premarket clearance.

Many Class 1 devices are exempt from the premarket notification (510(k)) requirement. However, manufacturers are still required to follow General Controls, such as proper manufacturing practices and facility registration.

Premarket Approval (PMA) is the most stringent type of device marketing application, required for all Class 3 medical devices. It requires manufacturers to provide extensive clinical and scientific evidence to prove the device's safety and effectiveness before it can be marketed.

Yes, reclassification can occur. The FDA may reclassify a device based on new information regarding its risks and benefits, or if new technology emerges that affects the device's risk profile.

The FDA maintains a database called the 'Product Classification Database' where you can search for a specific medical device and find its classification, regulatory requirements, and corresponding regulation number.

Accurate and clear labeling is a crucial aspect of regulatory controls across all classes. It ensures that users are provided with the correct information regarding a device's intended use, warnings, and proper handling, which is especially critical for higher-risk devices.

The classification system creates a clear regulatory pathway for manufacturers. While it places higher barriers for risky Class 3 devices, it also allows for quicker innovation in the lower-risk Class 1 and 2 categories, balancing safety with industry progress.