This week we are discussing what FDA classifies Class I Medical Devices as. Stay tuned for Class II and Class III 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 I 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 I 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 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 regulations regarding misbranding, adulteration, and false or misleading claims.
Do Class I Medical Devices Get FDA Approval?
No, class I 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 a Class I Medical Device?
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 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.