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What is a Class I FDA Medical Device Manufacturer and How Does it Benefit our Customers?

By May 19, 2022cold pack

The Federal Food, Drug, and Cosmetic Act was created in 1938 to protect the public from dangerous and ineffective drugs. In 1976, the act was revised in order to include medical devices. Under the revision, medical devices were placed into one of three classes based on the level of control required to ensure that they were safe and effective.

The following article describes these device classes, the registration requirements, and the risks involved with buying non-registered devices.

What are FDA Medical Device Classes?

The U.S. Food and Drug Administration (FDA) classifies medical devices into three classes, I, II, and III, depending on the regulatory controls needed to ensure that the products are effective and safe for consumer use.

Class I devices are not intended to support or sustain life or be used for substantial health-related purposes. They also may not pose an unreasonable risk of illness or injury. Class I devices must be registered by the manufacturer with the FDA.

Common kinds of Class I devices include:

  • Gel ice packs
  • Stethoscopes
  • Band-aids
  • Hydrogen peroxide

47% of FDA-approved medical devices are Class I, and among those, 95% are exempt from the PMA pathway to regulatory approval.

Class II devices include most surgical invasive devices, like heart valves and contact lenses, with low-to-medium risk. Gloves, magnetic resonating equipment, and needles are also classified as Class II.

What is the Canadian Equivalent of FDA Classes?

Health Canada Certified Products are the first Class of health products. Like the U.S. Class I medical devices, Canadian Class I devices include non-surgically invasive devices and wound care and are low-risk. Class II medical devices in Canada, including most surgical invasive instruments and contact lenses, are considered a low-to-medium risk.

What are the Registration Requirements For Companies?

All medical device manufacturers and companies annually register with the FDA and Health Canada. This process is called establishment registration and applies to all owners or operators of facilities involved in producing and distributing medical devices. The facility’s information is reviewed during the registration process, including all device listings.

A registration fees is collected each year.. Furthermore, medical device companies are required to detail all the devices they make (at each facility if the company owns or operates more than one) and the activities that are performed with each device. The FDA has an extensive, detailed list of where devices are manufactured to increase the country’s ability to respond and prepare for public health emergencies. Health Canada regulations state the manufacturer must be registered under an MDEL license to manufacture, distribute and-or import medical devices.

What are the Registration Requirements for Medical Devices?

Any medical device manufacturer of Class I, II, or III products is required to register the company and products with the FDA to sell or distribute the products in the U.S. legally. These products are listed on the FDA’s Registration & Listing database, and the FDA keeps a catalog of all products it regulates.

Manufacturers of devices that are exempt from regulatory processes, or those that make generic devices, must still register the company and products with the FDA in the appropriate generic category for the devices.

Registration of a device with the FDA means that the FDA is aware of the manufacturer and its devices. However, the device is not necessarily effective for the specific treatment applications that the manufacturer claims. This also means that the manufacturer is prohibited from claiming the device is “FDA approved” or cleared, and they may not use the FDA logo when labeling the device or marketing it.

The FDA administers a program called MedWatch, which monitors the safety of registered devices and products. Healthcare professionals, consumers, and patients can use the MedWatch program to report any medical product or device problems.

The Risks Involved with Buying Devices from Companies Who Are Not FDA Registered

Using a device that hasn’t been registered or cleared with the FDA can be risky. Not all medical devices bought and sold are registered with the FDA. Manufacturers in other countries may not register or list their devices with the FDA, nor do they go through pre-marketing processes. Therefore, the marketing and sale of these products is not considered legal.

Besides the fact that the products are illegal, using an unregistered device could be dangerous for a patient or could harm them. If you’re unsure if a medical device is listed with the FDA, you can search for the manufacturer in the Registration & Listing Database.

Choose Rapid Aid FDA Class I Registered Products For All Your Medical Supply Needs.

Rapid Aid products are FDA-registered and noted to be safe and effective for medical use. Do you have questions about our products or about FDA registration? Contact us today!