What is a Class 2 Medical Device? | HaA PD
What You Will Learn in This Article
How the FDA classifies medical devices into Class 1, 2, and 3 based on risk level.
What defines a Class 2 medical device, and why does it represent the largest category?
The regulatory requirements for Class 2 devices include 510(k) clearance and the Quality System Regulation (21 CFR Part 820).
The role of design controls in securing product safety, quality, and compliance.
Examples of standard and advanced Class 2 devices developed with expert support.
Introduction to Medical Device Classification
The United States Food and Drug Administration (FDA) categorizes medical devices into three different classes, depending on the level of regulatory control required to maintain both performance and safety. The FDA classifies Class II devices as medical devices that pose a moderate to high risk to both users and patients, requiring special controls to guarantee their safe operation beyond basic controls.
Class II devices are not considered as high-risk as Class III devices, but they still need considerably more oversight than Class I devices. Class II is the most prevalent classification in the medical device industry, accounting for forty-three percent of all medical devices.
How Are Medical Devices Classified in the US
The three classes defined by the US Food and Drug Administration (FDA) for the United States medical device market range from Class I to Class III. This class system is based on the progressive risk associated with the user or patient.
Class I devices pose the lowest risk, and Class III devices are of the highest risk, with each classification level having progressively more stringent regulatory control. This risk-based approach allows the FDA to implement controls that are proportional to the potential harm posed by the device.
Most medical devices can be classified by determining the corresponding description of the device in the specialty "panels" of Title 21 of the CFR. Title 21 of the Code of Federal Regulations (CFR) contains U.S. federal regulations for products regulated by the FDA and the DEA (Drug Enforcement Administration).
Class I
Class I devices pose the lowest risk and are typically subject to general and straightforward controls, including registration, listing, and labeling requirements. Examples of Class I devices include: bandages, plasters, medical spoons, glasses, and stethoscopes. The majority of these are exempt from the requirement for premarket notification.
Class II
Class II devices pose a slightly higher to moderate risk and, therefore, require general controls and some special controls, which may include performance standards, special labels, or post-market surveillance. Examples are contact lenses, biopsy forceps, hearing aids, and infusion pumps. The majority of these devices need a premarket notification, which is a submission made to the FDA to show that the device is substantially equivalent (as safe and effective as a device already legally marketed and available on the market)
Class III
Class III devices have the highest risk factor and need general controls, as well as premarket approval (PMA). This type of device is typically a life-sustaining or life-support device, or one that can pose a risk of injury or illness. Examples are pacemakers, defibrillators, cochlear implants, and heart valves.
What Makes a Medical Device Class II?
The most common medical devices in the U.S. are classified as Class II and pose only a moderate risk. These devices occupy the space between simple medical devices and complex life-supporting ones, necessitating skilled regulatory advice to strike a balance between innovation and the secure delivery of healthcare.
As a manufacturer, medical professional, or patient, you must have a clear view of what constitutes a Class II medical device. Such medical devices include powered wheelchairs, pregnancy test kits, catheters, blood pressure cuffs, contact lenses, and surgical gloves. Their characteristics usually include the following:
Special controls
Special controls include special labeling requirements, performance standards, or measures that are to guarantee safety.
510(k) clearance
For Class II devices, this means obtaining a PMA (Premarket Approval), which requires demonstrating substantial equivalence to a device that is currently legally marketed.
Examples of Class 2 Medical Devices
At HaA PD, we provide medical device development services from concept and design through to testing and the manufacture of the finished item. Here are some Class II medical devices that we helped produce:
AngioDynamics’ Gen 4 Cannula
The AngioDynamics Gen 4 Cannula is a device designed to provide greater precision in procedures that remove emboli from the pulmonary artery.
Cobra Lighted Retractor
The Cobra Lighted Retractor improves visibility during hip procedures.
Swallowable Gastric Balloon
The Swallowable Gastric Balloon eliminates the need for anesthesia or endoscopy for patients requiring weight loss.
Radiadyne’s Radiation Dose Monitoring
Radiadyne’s Radiation Dose Monitoring measures radiation doses for cancer patients.
Perma Pure’s Prescription Humidifier
The Perma Pure Prescription Humidifier is a compact, biocompatible humidifier designed for use with oxygen concentrators in both clinical and home care settings.
Verb Surgical’s Digital Surgery Platform
Verb Surgical’s Digital Surgery Platform is a next-generation robotic platform designed to improve surgeon control and patient safety.
Vacuum-Assisted Sternotomy Retractor
The Vacuum-Assisted Sternotomy Retractor is used for open-heart procedures.
Smith and Nephow CDS System
The Smith and Nephew CDS System is a device designed to assist doctors performing spinal disc procedures.
HFDA Requirements for Class 2 Devices
FDA Class II devices require strict regulation to guarantee device effectiveness and the utmost safety of patients. These devices are usually subject to both general controls and special controls before they can be legally sold in the United States.
The most significant condition to adhere to for a Class II medical device is submitting a premarket notification or a 510(k) clearance. As a manufacturer, you must demonstrate that your device is "substantially equivalent" to a legally marketed device that already exists, referred to as a predicate. “Substantial equivalence” means that the new device is as safe and effective as, if not more so, than the existing one and does not raise new questions about safety or performance. The FDA reviews the device's 510(k) submission to confirm that the new device meets the applicable requirements before it is marketed.
Under 21 CFR Part 820, Class 2 device manufacturers must comply with Quality System Regulations (QSR). QSR governs all aspects of design, manufacturing, packaging, labeling, storage, and installation. A key component of QSR compliance is design control, which requires you to document, validate, and systematically manage the design process to guarantee product quality and regulatory compliance.
Any medical device developer that fails to comply with FDA standards can be subject to enforcement action, including warning letters, product recalls, injunctions, or civil penalties. It is therefore imperative for Class II medical device-producing companies to be aware of and meet all the applicable FDA regulations as a way of maintaining public health and business success within the medical device industry.
The Approval Process of Class 2 Devices
FDA approval for a Class II medical device is a step-by-step process outlined in their regulations. Follow the steps listed below to successfully clear your Class II medical device, for compliance with all necessary FDA regulations, and bring your new medical product safely to market in the U.S:
Step 1: Classify your device
The first step is to classify your device in the FDA's Product Classification Database to determine its risk classification. The process involves defining what the device’s intended use is and identifying the medical specialty that best suits it. If the device is a moderate-risk (Class II) device, it requires a 510(k) submission.
Step 2: Establish a regulatory strategy
The second part of the process involves establishing a regulatory strategy. Choose an already legally marketed predicate device to demonstrate "substantial equivalence" and establish required testing (e.g., performance, biocompatibility, electrical safety).
Implement a Quality Management System (QMS) compliant with 21 CFR Part 820, potentially integrating with ISO 13485 to guarantee uniformity in design, manufacturing, and documentation. At the core of QMS is the maintenance of a Design History File (DHF), which records inputs, outputs, verification, validation, design reviews, and changes in accordance with FDA design controls.
Step 3: Submit your 510(k)
Upon the completion and finalization of the design and testing, submit a 510(k) premarket notification that compiles device description, predicate comparisons, test reports, labeling, and intended use. Note that you can initiate a Q-Submission meeting with the FDA to clarify requirements before submission.
Step 4: Clearing
Once your 510(k) is submitted, the FDA will review it; they may issue "deficiencies," with responses expected promptly.
You should typically receive clearance within approximately six months; however, delays may occur if you are not working closely with regulatory experts who are familiar with the regulations and understand how to manage the process thoroughly and effectively. Our experts are familiar with this system and the numerous processes it entails, which can save you both time and money.
After clearing, a “device listing and establishment registration” is completed with UDI under 21 CFR Part 801, along with “post-market surveillance.”
Take the Next Step Toward FDA Clearance
A new Class II medical device requires more than innovation. You need a clear regulatory path, strong documentation, and expert support. HaA PD helps medical device designers move from concept to a compliant product with confidence.
Consult HaA PD today. Our experts can help your medical device designs align with FDA requirements and streamline your 510(k) submission process.
Key Takeaways
Class 2 medical devices pose a moderate to high risk and account for approximately 43% of all FDA-regulated devices.
They require 510(k) clearance, showing substantial equivalence to a legally marketed predicate device.
Must comply with 21 CFR Part 820 (Quality System Regulation), including strict design controls to provide safety and performance.
Examples include contact lenses, catheters, surgical gloves, and powered wheelchairs.
Noncompliance can lead to FDA enforcement actions; expert guidance helps streamline the regulatory and clearance process.
