Difference between FDA Cleared vs FDA Approved – Overview
The Food and Drug Administration (FDA) regulates the sale of medical devices in the United States to ensure consumer safety. Generally, every medical device sold in the US is classified into one of three classes, according to their potential risk to the consumer.
For instance, Class I and Class II medical devices pose low to moderate risks to consumers, so manufacturers may not need to get an FDA clearance for these devices. However, class III devices have a greater potential risk to consumers, so these undergo a thorough review before being granted FDA approval. Additionally, if the device does not require FDA clearance, the device still needs to be registered with the FDA.
In essence, any commercially sold medical device in the US must get FDA approval or at least an FDA clearance before being sold. This is essential to protect users from potential harm while using these medical devices.
FDA Classes for Medical Devices
A medical device is defined as any item used to manage or treat a health condition or an item that can change or interact with a part of the body without using medications. Such devices include a large variety of tests and equipment, all the way from simple gauze bandages to pacemakers used for heart problems.
As mentioned previously, the FDA classifies a medical device into one of three classes based on its potential level of risk to the user.
Class I Medical Device
The FDA defines a Class I medical device as any device that carries the lowest risk of complications to the patient/user and usually does not require a premarket review. This is the review that the FDA uses to decide the level of safety and effectiveness of medical devices.
Class I medical devices can be sold/marketed as “FDA Listed” or “FDA Registered.” It means that the FDA is aware of the device being sold in the market but has not reviewed it for safety and effectiveness.
Such medical devices still need to adhere to certain manufacturing and quality standards during manufacturing. Examination gloves and bandages are examples of Class I medical devices.
Class II Medical Device
A Class II medical device is any device that poses a moderate risk to consumers and needs to demonstrate that it is “substantially equivalent” to similar products that have received FDA clearance. Most Class I medical devices are marketed as “FDA Cleared” devices. These include infusion pumps used to administer intravenous (IV) medication.
Class III Medical Device
Class III medical devices tend to pose the highest level of risk to consumers. These devices are still crucial for life support and may even prevent significant harm to health, but they also pose a substantial risk of injury or illness to the users.
The FDA completely reviews such medical devices before being “FDA Approved.” Class III medical devices usually include items such as pacemakers that are implanted in the heart.
FDA clearance is usually granted for Class II medical devices. However, several Class I device manufacturers also frequently seek FDA clearance. Manufacturers can get FDA clearance by providing information proving that their device is substantially similar to another FDA-cleared product.
The definition of “substantially equivalent” by the FDA includes the following characteristics:
- The device uses the same technology and will be used for a singular purpose, similar to an existing FDA-approved
- The device has a different technology but is designed for use similarly to an existing FDA-approved medical device. In this case, the manufacturers will need to provide additional information and evidence to prove the safety and effectiveness of their devices.
As Class I and Class II medical devices pose low to moderate risk to consumers, the process used by the FDA to review such products is less stringent than that for approving medications or Class III devices.
A manufacturer of medical devices is required by the FDA’s Food, Drug, and Cosmetic Act Section 510(k) to register their medical devices before selling their products in the market.
Thus, manufacturing companies can submit a 510(k) (premarket notification – PMN) to the FDA that shows the device is substantially similar to an existing device in the market.
Premarket Approval (PMA) is a stringent application that manufacturing companies must submit before marketing any new product. Class III medical devices have the highest potential risk to users, so they undergo the strictest PMA process before being sold anywhere in the United States.
Manufacturers of medical devices need to submit information and evidence to the FDA that proves the medical device is safe and effective. PMA applications are scientific and legal documents and should include the device’s clinical and technical details.
PMA applications usually contain two types of information:
- Nonclinical laboratory studies sections – The manufacturer has to include practical information about the device, including compatibility, shelf-life, chemistry, and other relevant scientific information.
- Clinical investigations sections – In this section, the manufacturer has to include information from clinical trials, which include safety and effectiveness data, complaints from study participants, side effects, and any device failures.
The FDA determines if the device can be approved based on this information.
The FDA works hard to ensure that any medical device in the market is safe and effective for consumer use through stringent standard tests. It designates medical devices into one of three Classes – I, II, and III – based on the level of potential risk that the medical device poses to users. Class I and II medical devices have a low to moderate risk of complications from use, while Class III medical devices have a higher risk of complications.
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