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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.
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, 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.
Class 3 medical devices (high risk) are subject to both general and special controls as well as PMA from the FDA to be legally marketed in the US.
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 the Good Manufacturing Processes (GMPs) for medical devices and certain quality activities under 21 CFR Part 820, 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.
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.
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 cClass 1 medical devices during a routine trip at the doctor’s office without thinking of them as medical devices at all.
Examples of Class 1 medical devices include:
Irrigating dental syringes
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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Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...