Class 1 Medical Device – Overview
The Food and Drug Administration (FDA) is responsible for regulating the medical device market in the United States.
To be more specific, the FDA’s Center for Devices and Radiologist Health (CDRH) deals with regulating medical devices to ensure their safety and efficacy for patients.
Every medical device is different. Hence, it is not practical to categorize every similar device within the same class.
This is essential from the point of view of regulatory control and oversight before the product is launched in the market.
The FDA uses a three-tier system of classification to identify the level of regulatory control and to distinguish between different medical devices.
This classification system is mainly based on the potential risk to patients from the device.
What are the different Medical Device Classes?
The US FDA classifies any new medical device under one of three classes – Class 1, Class 2, and Class 3. These medical device classes define the level of the potential risk posed by them to the patient.
Let’s check out the three classes of medical devices:
Class 1 Medical Devices
Class 1 medical devices have the lowest potential risk and are subject to general regulatory controls. Manufacturers of class 1 devices are not required to submit pre-market approval from the FDA.
These devices also are not subject to the same requirements of 21 CFR Part 820, which the other two classes need to comply with.
Class 2 Medical Devices
Class 2 medical devices have a noticeably higher risk potential than Class 1 but less than Class 3 devices.
These medical devices are also subject to the regulations applied to Class 1 devices.
Apart from these, Class 2 medical devices are also subject to post-market surveillance, performance standards, and pre-market notification requirements.
This is known more commonly as a 501(k) submission. This is essential to receive FDA clearance to legally sell the device in the consumer market.
Class 3 Medical Devices
Class 3 medical devices are those that pose the greatest potential risk to patients. These are usually devices that connect directly to a patient’s internal organs or are significantly invasive.
These are usually life-supporting and life-sustaining medical devices. Those devices that help to prevent unreasonable risk of injury or illness are classified under this category.
These devices are subject to general and special regulatory controls. Manufacturers of class 3 medical devices need to get a PMA (Pre-Market Approval) from the FDA before launching their products in the market.
Is there any Class 1 Exemption for Medical Devices?
Depending on their lower risk levels, Class 1 medical devices are subject to lesser numbers of regulatory requirements.
These types of devices are usually the easiest to launch in the consumer market.
Almost all Class 1 medical devices are exempt from submitting a PMA (pre-market approval) for FDA clearance.
These devices are also exempt from the GMP (Good Manufacturing Processes) for medical devices.
These are also exempt from certain quality activities under 21 CFR Part 820, such as proving and documenting design controls.
In case you are unsure whether your device is exempt, you can easily check the FDA’s approved Class 1 device list by clicking on this link https://www.accessdata.fda.gov/.
Besides this, you can also choose to view the FDA’s Product Classification database by clicking on this link https://www.accessdata.fda.gov/.
This way you can search for specific types of devices and determine if certain exemptions apply to your product.
It is important to remember that Class 1 medical devices still need to adhere to several conventional regulatory requirements, such as general controls.
What are the Class 1 Regulatory Controls for Medical Devices?
As mentioned earlier, Class 1 medical devices are subject to general controls. These FDA regulatory requirements apply to every medical device marketed in the United States unless the FDA specifically exempts it.
The sections which dictate general controls are authorized by the Federal Food, Drug, and Cosmetic (FD&C) Act, and include:
- Sections 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
You must remember that Class 1 medical devices have fewer regulatory controls than devices from other classes.
Most of these requirements will need a high degree of organization and documentation within your QMS. This is especially true if your device falls under Section 519.
Which devices come under Class 1?
Almost half of all medical devices fall under Class 1. In general, these are devices that have limited contact with patients.
Their impact on the patient’s health is not too significant. You might have used a number of Class 1 medical devices on a routine visit to your doctor’s clinic.
Some commonly used Class 1 medical devices include:
- Latex gloves
- Tongue depressor
- Irrigating dental syringes
- Surgical masks
Although Class 1 medical devices are subject only to general controls, there are still significant requirements that need to be fulfilled by manufacturers.
It is extremely crucial for device manufacturers to ensure that they register their devices in the correct category and ensure smooth, streamlined manufacturing to market process.