FDA Approval vs. FDA Clearance: What Are the Differences? - GoodRx (2024)

Bandages, blood pressure monitors, and insulin pumps — what do these products have in common? They are all medical devices. And some medical devices must be FDA cleared or FDA approved before being marketed and sold in the U.S. This is done to protect the public from potential harm while using these devices.

However, FDA clearance and approval are not the same. Read on to learn more about how the FDA reviews information on medical devices and when products become FDA cleared or FDA approved.

Three FDA classes of medical devices

A medical device is defined as an item used to manage or treat a health condition, or as an item that can change or interact with a part of the body without using medications. Medical devices encompass a wide array of tests and equipment, ranging from gauze pads to ventricular assist devices (VAD) used for heart failure.

The FDA groups devices into three different classes based on their potential risks to the public:

• Class I: Since these medical devices carry the lowest risk to consumers, they usually don’t require a premarket review. This review is how the FDA determines a device is safe and effective. Class I devices may be marketed as “FDA listed” or “FDA registered.” This simply means the FDA knows the device is being sold but hasn’t reviewed its safety and use. While being made, these devices still must meet certain manufacturing and quality standards. Examples of Class I devices include bandages and exam gloves.

• Class II: These medical devices have a moderate risk to consumers and must demonstrate that they are “substantially equivalent” to similar products that have already received FDA clearance. Most of these products will be marketed as “FDA-cleared” devices. Class II devices include infusion pumps used to give intravenous (IV) medications.

• Class III: Medical devices in this class carry the highest risk to consumers. These devices may be crucial in supporting life, may help prevent significant health harms, or may pose a substantial risk of injury or illness. These products are thoroughly reviewed by the FDA before being classified as “FDA-approved” devices. Pacemakers used to control a person’s heartbeat are an example of a Class III device.

FDA clearance

FDA clearance is generally granted for Class II medical devices. Some Class I device manufacturers may also seek FDA clearance. Companies can receive FDA clearance by providing information that their device is substantially equivalent — or similar — to another FDA-cleared product.

The FDA may consider a device to be substantially equivalent if they meet the following qualifications:

• The device uses the same technology and will be used for the same purpose as an existing device.

• The device will be used for the same purpose as an existing device but uses different technology. However, this technology doesn’t raise concerns about its safety or effectiveness. In this case, the manufacturer would have to provide additional evidence showing that the product is safe and effective.

Since Class I and II medical devices pose low-to-moderate risk to consumers, the FDA review process for these products isn’t as strict as it is for approving medications or Class III medical devices.

510(k) submission process

The Food, Drug, and Cosmetic Act section 510(k) requires companies to register medical devices before marketing their products. Companies can submit a 510(k) — also known as a premarket notification (PMN) — to the FDA to show that the device is substantially equivalent. This process is usually applicable for Class II devices.

The 510(k) clearance process doesn’t require companies to provide safety or effectiveness data from clinical trials. But the FDA still evaluates the device's safety and effectiveness by comparing it to other devices. The FDA requires that companies submit a 510(k) at least 90 days before marketing the device.

Since clinical study data isn’t typically evaluated, the FDA completes 510(k) reviews relatively quickly. Most products are granted 510(k) clearance within 3 months. For devices submitted between October 2021 and September 2022, the cost of a 510(k) submission will range from $3,186 for small businesses to $12,745 for standard businesses.

FDA approval

Premarket approval (PMA) is the strictest application that companies have to submit before marketing a new device. Since Class III medical devices carry the highest risk to consumers, they must go through PMA before being marketed in the U.S.

Companies must submit information and evidence to the FDA proving that the medical device is both safe and effective. PMA applications are both scientific and legal documents. They must include both technical and clinical information about the device.

PMA applications contain the following information:

• Nonclinical laboratory studies sections: This includes practical information of the device, such as the shelf life, compatibility, and chemistry or other scientific information.

• Clinical investigations sections: This includes information from clinical trials, such as safety and effectiveness data, side effects, device failures, and complaints from study participants.

  See Also

  The 2021 MPO Top 30 Medical Device Companies Report

Upon reviewing this information, the FDA will determine if the device can be granted approval. Medical devices that have received PMA can be found on the FDA’s PMA database.

Since the FDA will need to carefully review the submitted information, the PMA review process can be lengthy. Although it generally takes 6 months to complete, the FDA may sometimes take longer to decide on the device’s approval, especially if the application has missing or inadequate information.

Compared to 510(k) submissions, the cost of a PMA application is much more expensive. Costs between October 2021 and September 2022 will be $93,714 for small businesses and $374,858 for standard businesses. However, some small businesses may qualify to have their first PMA fee waived.

Companies may also submit a humanitarian device exemption (HDE) application for Class III devices that treat or diagnose rare conditions. This application would be used instead of a PMA application. Generally, these devices would be used by less than 8,000 people in the U.S. each year.

Although HDE applications are very similar to PMA applications, they don’t have the same effectiveness requirements. Because these conditions are rarer, it would be much harder for companies to provide the same clinical trial data. This is because less people are available to enroll in clinical trials.

Can you legally sell a medical device in the U.S. without FDA approval?

In short, no. In order to market or sell a medical device, it must be registered, cleared, or approved by the FDA.

In 1976, Congress amended the Federal Food, Drug, and Cosmetic Act to allow the FDA to regulate medical devices before they’re legally sold in the US. This was done to ensure safety and effectiveness.

This legislation amendment introduced the three device classes mentioned above. It also gave the FDA authority to ban the sale of medical devices deemed unsafe or ineffective.

Based on the device’s classification, the FDA may clear or approve a medical device before it’s marketed in the U.S. Most Class I and some Class II devices don’t require FDA clearance or approval. Typically, these devices — like bandages or stethoscopes — are low risk and don’t need to prove their safety or effectiveness.

But even if a device doesn’t need FDA clearance or approval, it still needs to be registered in order to be sold. You can check whether a medical device is approved or cleared by searching in the Devices@FDA database.