In the US, the governing body tasked with regulating the medical device market is the Food and Drug Administration (FDA). More specifically, the Center for Devices and Radiological Health (CDRH) is the specific branch within FDA responsible for regulating medical devices and ensuring its safety and efficacy for patients.
Not all medical devices are alike, which means not all medical devices face the same level of regulatory control and oversight before and after they are placed on the US market.
To distinguish between the different types of devices and the level of regulatory control needed, FDA uses a three-tier system of classification based on risk.
This article will cover what manufacturers need to know about the first of these classes and discuss what is a class 1 medical device.
Class 1 vs Class 2 vs Class 3: quick comparison
Risk level |
Regulatory controls |
Typical premarket pathway |
Examples |
|
|---|---|---|---|---|
|
Class I
|
Low |
General controls |
Most are exempt from 510(k) |
Bandages, stethoscopes, tongue depressors |
|
Class II
|
Moderate |
General + special controls |
Usually 510(k) clearance |
Infusion pumps, powered wheelchairs, pregnancy test kits |
|
Class III
|
High / life-sustaining |
General controls + PMA |
Premarket approval (PMA) |
Implantable pacemakers, heart valves |
What are the different FDA medical device classes in the US?
Medical devices in the US are classified as one of three different types according to the risk of a device’s intended use and its indications for use.
Class 1 medical devices
Class 1 medical devices, notated as class I devices by FDA, are associated with the lowest risk and are therefore subject only to general controls—the lowest level of regulatory controls.
Manufacturers of most Class 1 devices are not required to submit a premarket notification nor are they subject to the same requirements of 21 CFR Part 820 that the other two classes must follow for compliance.
Class 2 medical devices (moderate to high risk) are subject to the same general controls as Class 1, plus special controls, and most require a 510(k) premarket notification before marketing.
Class 3 medical devices (high risk: devices that sustain or support life, are implanted, or present potential unreasonable risk) are subject to general controls and require premarket approval (PMA) from FDA to be legally marketed in the US.
What Class 1 exemptions exist for medical devices?
Because of their low-risk level, class 1 medical devices are subject to the fewest regulatory requirements and are generally the easiest devices to bring to market.
Nearly all Class 1 medical devices are exempt from submitting a premarket notification or PMA application for FDA clearance or approval for market.Class 1 devices may also be exempt from certain good manufacturing practice requirements and quality activities under FDA’s quality management system regulation — since February 2, 2026, the QMSR, which incorporates ISO 13485:2016 — such as establishing and documenting design controls.
If you’re uncertain of whether your device is exempt, you can check the FDA’s list of devices exempt from premarket notification and GMPs. You can also use the FDA’s Product Classification database to search for a specific type of device and determine whether certain exemptions apply.
Keep in mind, however, that just because a Class 1 device is exempt from premarket notification or GMP requirements doesn’t mean they are exempt from other regulatory controls—such as general controls—unless explicitly stated by FDA.
Do Class 1 medical devices need a 510(k)?
Most do not. The majority of Class I devices are exempt from premarket notification. But exempt from 510(k) is not exempt from FDA: manufacturers must still register their establishment, list their devices with FDA, comply with applicable general controls, and label devices properly, including UDI requirements where they apply.
A small number of Class I “reserved” devices do require a 510(k). Always confirm your device’s status in FDA’s Product Classification database or via FDA’s Q-Sub program before assuming an exemption.
What regulatory controls apply to Class 1 devices?
As mentioned previously, Class 1 devices are subject to general controls. These are FDA regulatory requirements that apply to all medical devices marketed in the US, unless FDA specifically notes that a device is exempt.
General controls are authorized by the Federal Food, Drug, and Cosmetic (FD&C) Act, and they can be found in the following sections of the act:
-
Section 501 - Adulteration of devices
-
Section 502 - Device misbranding
-
Section 510 - Device registration
-
Section 516 - Banned devices
-
Section 518 - Notification and other remedies
-
Section 519 - Records and reports
-
Section 520 - General provisions
It’s important to note that while Class 1 devices are subject to fewer regulatory controls than other device classes, many of the requirements still necessitate a high degree of documentation and organization within your QMS, especially those within Section 519. For instance, Complaints and Adverse Event Reporting and Removals and Corrections must still be documented and stored in your QMS.
These and other Current Good Manufacturing Practices (cGMP) are significantly easier to perform on Greenlight Guru's Quality Management Software. It's designed to help MedTech teams deliver innovations to market, streamline compliance, and focus on quality — all in one end-to-end platform.
Examples of Class 1 medical devices
Nearly half of all medical devices are Class 1 devices, covering a wide variety of uses and end users. Generally speaking, class 1 devices have limited contact with patients and their impact on a patient’s health is slight.
In fact, you probably encounter a number of Class 1 medical devices during a routine trip to the doctor’s office without thinking of them as medical devices at all.
Examples of Class 1 medical devices include:
-
Stethoscopes
-
Bandages
-
Bedpans
-
Tongue depressors
-
Latex gloves
-
Surgical masks
-
Irrigating dental syringes
Get to market faster with the only QMS Built just for medical devices
While it’s true that Class 1 medical devices face the simplest regulatory path to market, there are still plenty of requirements, like general controls, that will more than likely apply to your Class 1 device.
At Greenlight Guru, we believe every medical device company should go beyond baseline compliance to focus on true quality, regardless of their device’s classification. It's why we built ISO 13485-compliance and medical device best practices into our industry-leading QMS platform. With Greenlight Guru, you get the only #1 modern QMS, purpose-built to give MedTech companies an end-to-end system to manage the lifecycle of their product — all in one place.
Get to market faster with the only QMS built exclusively for medical device companies to help you achieve true quality. Get your free demo of Greenlight Guru today!
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Step-by-Step Guide to Medical Device Classification
Step-by-Step Guide to Medical Device Classification
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