Medical devices sold in the U.S. often carry designations like FDA registered, FDA approved or FDA cleared.
However, for most consumers, this terminology is confusing. Many have a similar question: When I shop for medical devices (for home or clinical use), what FDA status should I look for?
In general, it depends on the type of medical device you need and its intended use. For example, the requirements for a pacemaker implant are different than a red light therapy device, as the potential risks of an implant are much higher.
Ultimately, FDA approval, registration and clearance status can be difficult to understand. This guide provides an overview of these designations, as well as an in-depth look at requirements.
All of Hue Light USA’s medical devices meet FDA registration requirements. (And we’ll walk you through exactly what that means below.)
Why Does the FDA Monitor Medical Devices?
The Food and Drug Administration (FDA) has a primary role of protecting public health in the U.S. Therefore, it closely monitors the safety of medical devices and consumer products sold here.
The FDA regulates a wide variety of products. For example, the FDA is responsible for regulating medicines and vaccines, as well as products like tobacco, vape and some electronics like microwaves. Therefore, the FDA monitors the safety of these products and sets standards for various products to protect public health.
With medical devices, the FDA sets standards based on the potential risk a device poses. Higher risk devices (Class III), for example, have a different set of standards compared to lower risk devices (Class I and Class II).
FDA Medical Device Classes (I, II and III)
Device classes are set by the FDA. They are based on the level of risk they pose to the user. But also, the degree of regulatory control needed to ensure safety. Here’s a look at the FDA’s specific medical device classes:
Class I Medical Devices
- Risk Level: Low risk to the user.
- Examples: Elastic bandages, tongue depressors, and non-powered breast pumps.
- Regulation: Subject to general controls, and most are exempt from premarket notification requirements. Approximately 95% of Class I devices are exempt from regulatory processes.
Class II Medical Devices
- Risk Level: Medium risk.
- Examples: Motorized wheelchairs, pregnancy test kits, dialysis equipment, many types of catheters, and the Apple Watch ECG app.
- Regulation: Require FDA clearance through the Premarket Notification 510(k) process, demonstrating that the device is substantially equivalent to a legally marketed predicate device. Some Class II devices are exempt from regulatory processes.
Class III Medical Devices
- Risk Level: High risk, often life-sustaining, implanted into the body, or pose a significant risk to the patient.
- Examples: Pacemakers, breast implants, replacement heart valves, and mechanical heart valves.
- Regulation: Require FDA approval through the Premarket Approval (PMA) process, where manufacturers must provide valid scientific evidence of the safety and effectiveness of the devices for their intended uses.
These classifications help in determining the level of regulatory scrutiny and approval process needed before the devices can be marketed and used in the United States.
FDA Registered vs FDA Approved vs FDA Cleared
Depending on the medical device class, the device may be required to meet specific FDA requirements, e.g. FDA Cleared or FDA Approved. However, all medical device companies must first register with the FDA.
Here’s an overview of each of these terms:
Medical device companies must register their products with the FDA. Registration means the FDA is aware of the manufacturer and their devices, but it does not imply effectiveness for specific treatment applications. The manufacturer cannot claim that the device is “FDA Cleared or Approved” based on registration alone.
Class II devices, which are moderate-risk medical devices, require FDA clearance. Manufacturers meet this requirement by completing the Premarket Notification 510(k) process. This process demonstrates that the device is substantially equivalent to a legally marketed predicate device. However, some devices are exempt from the Premarket Notification process. Devices that are FDA cleared cannot be marketed as “FDA Approved.”
The FDA requires approval for the highest-risk devices (Class III), such as mechanical heart valves and implantable infusion pumps. Manufacturers must demonstrate with valid scientific evidence that these devices are safe and effective for their intended uses. The FDA also requires approval for new medicines, vaccines, animal drugs, food additives, and human cells and tissues.
What’s the Difference between FDA Approved vs FDA Cleared?
These FDA designations are reserved for different types of devices. Class II devices earn FDA clearance, while Class III devices and products must earn FDA approval.
About Our FDA Registered Devices – Hue Light
The Hue Light USA product line meets FDA registration requirements for Class I or Class II devices. For example, our Class I devices meet the baseline requirements, while our Class II devices (our PBM products) are exempt from the Premarket Notification process.
Some Class II devices are exempt from the Premarket Notification process. This is because the FDA determined that these Class II devices are sufficiently well understood and do not pose a significant risk to users. Here’s why certain Class II devices are exempt:
- Well-Established Safety Profile
Some Class II devices have been in use for a long time. In addition, they have a well-established safety profile. The FDA may have sufficient information and experience with these devices to determine that they are safe and effective for their intended use.
- Low to Moderate Risk
Class II devices are generally of moderate risk. However, within this classification, there can be variations in risk levels. Devices that are on the lower end of the risk spectrum within Class II may be suitable for exemption.
- Standard Controls
The FDA may determine that general controls are adequate to assure the safety and effectiveness of the device, making premarket notification unnecessary.
Ultimately, by exempting certain devices, the FDA can allocate more resources to focus on evaluating high-risk devices.
Hue Light registered all of our medical devices with the FDA. Safety is a top priority for Hue Light USA, and we’ve taken steps to ensure the safety of our products. In addition to FDA registration, our entire product line is:
- RoHS Complaint – Our products do not include hazardous materials set by the Restriction of Hazardous Substances (RoHS) standards set in the EU. This includes materials like mercury and lead (RoHS check mark).
- Conformite Europeenne – Our products comply with the safety, performance and environmental standards set by the EU (CE mark).
- International Electrotechnical Commission – Hue Light USA’s products meet IEC safety regulations for electronically powered devices, ensuring safe performance (IEC mark).
Do you have questions about FDA registration or other safety standards? Contact Hue Light USA today to learn more about commitment to safety and for specific safety information regarding our products.