This week we are discussing what FDA classifies Class 1 Medical Devices are. Stay tuned for device Class 2 and Class 3 in the coming weeks!
The FDA plays an essential role in protecting public health by regulating health products. To regulate medical devices, the FDA has a number of different requirements. However, not all medical devices need the same level of FDA regulatory scrutiny. FDA classified medical devices based on the risk profile of the device. The least risky medical devices are called “class I” medical devices.
What is a Class 1 Medical Device?
FDA definition of Class I Medical Devices
“not intended for use in supporting or sustaining life or of substantial importance in preventing impairment to human health, and they may not present a potential unreasonable risk of illness or injury.”
Roughly 50% of all FDA-regulated medical devices are class I devices.
A class I medical device has a low risk-to-benefit profile. What that means is that these products are well established, and there are non-significant consequences or injuries associated with the misuse. Class I devices are non-life sustaining or life-supporting, and diagnoses from a class I device would not be life-altering. Several day-to-day products are class I medical devices like bandages or toothbrushes, and even hospital products like bedpans are class I medical devices.
What Are the Regulatory Requirements for a Class I Medical Device?
Manufacturers or distributors of FDA class 1 devices must comply with FDA’s registration activities for class I products. Typically class I medical devices do not require a 510(k), also known as 510(k) exempt. To determine what are the requirements, manufacturers should use the FDA’s classification regulations to identify the requirements for their specific product. Typically manufacturers and distributors will need to comply with FDA’s registration activities and list their device or equipment on FDA’s device registration and listings.
Class I medical device manufacturers and distributors are still subject to the FDA’s requirements for marketing claims. These products are still subject to FDA’s device regulations regarding misbranding, adulteration, and false or misleading claims.
Do Class I Medical Devices Get FDA Approval?
No, class 1 medical devices are not FDA approved. The FDA does not approve most medical devices. The FDA regulates the marketing and distribution of medical devices. Class I devices cannot claim they are “FDA approved.” Typically only class III devices that undergo a “Premarket Approval Application” (PMA) can claim to be FDA approved.
What are the Regulatory Timelines for Registering Class I Medical Devices?
Class I medical devices have a simpler pathway. Once manufacturers or distributors have products with the appropriate manufacturing controls, then they can register their establishment and list their device on the FDA’s “Establishment and Device Listings” and begin distribution immediately. Annual manufacturers and distributors need to re-list their products.
Contact a Qualified Medical Device Design and Development Company Today
If you are looking for support with bringing a medical device to market, DeviceLab is here to help. Whether you have a class I, class II, or class III device, DeviceLab has experts to help you with design, prototyping, manufacturing, regulatory, and marketing to bring your product to patients and providers. Contact DeviceLab to schedule a consultation.
Frequently Asked Questions About Class 1 Medical Devices
What is the Difference Between Class 1, Class 2, and Class 3 Medical Devices?
- Class 1 Devices are considered low risk and are subject to the least regulatory control. They do not support or sustain life and have minimal potential to cause harm.
- Class 2 Devices are higher risk than Class 1 and require greater regulatory control to provide reasonable assurance of the device’s safety and effectiveness. Most Class 2 devices require a 510(k) premarket notification.
- Class 3 Devices are the highest risk devices and require the most stringent regulatory scrutiny, including premarket approval (PMA). These devices usually support or sustain life, are implanted, or present potential unreasonable risk of illness or injury.
What is Medical Device Risk Class I?
Medical device risk Class I refers to devices that pose the lowest risk to the patient and/or user. These devices are often simple in design, have a long history of safe use, and are unlikely to cause significant harm if they fail. The regulatory requirements for Class I devices focus on ensuring that the device is properly labeled, manufactured under quality standards, and registered with the FDA.
How Do I Get a Class 1 Medical Device Approved?
While Class 1 devices are not “approved” by the FDA in the sense that Class 3 devices are, they must still be registered with the FDA. To get a Class 1 device on the market, you need to ensure the device complies with general controls, register your establishment with the FDA, and list your device in the FDA’s database. It’s crucial to maintain compliance with all applicable FDA regulations for manufacturing practices and product labeling.
List of Class 1 Medical Devices:
Beyond the examples mentioned like bandages and toothbrushes, other Class 1 devices include examination gloves, hand-held surgical instruments, and elastic bandages. These are all products that are deemed to have minimal potential for harm to the user and are primarily subject to general controls.
