How to choose which FDA regulatory process is right for your device

Whether it’s a tongue depressor or an X-ray machine, all medical devices have to first go through the FDA to ensure they’re safe for patient use. But not every device can receive FDA approval.

The FDA uses a risk-based classification to determine whether to grant clearance or approval to medical devices. The higher the classification, the more regulatory controls are required to ensure the device’s effectiveness and safety.

FDA classifications

Class I devices present the lowest risk, and are usually exempt from many statutory and regulatory review requirements, even though device manufacturers must register with the FDA and list their devices with the agency.

This class includes products like dental floss; it’s not likely that “there’s going to be a risk of harm,” Benjamin Zegarelli, an attorney who advises clients on FDA regulations at Mintz law firm, told Healthcare Brew.

Class II devices exhibit moderate risk and are the largest class of devices the FDA reviews, according to Zegarelli. These devices require specific controls to ensure their safety, such as “performance standards, postmarket surveillance, [or] patient registries,” according to a Congressional Research Service report.

The FDA, for example, recommends special controls such as stability testing to determine the shelf life of electrocardiograph electrodes, the small patches that attach to the skin to measure the heart’s electrical activity.

Class III devices have the highest associated risks and include life-sustaining devices or implants, Zegarelli said. However, this category also includes novel devices that the FDA has never seen before.

“The reasoning being that the FDA doesn’t know what it is [and] doesn’t have experience with the special controls required,” Zegarelli said.

For example, SureTune4 Software, a brain stimulation programming planning software, was first categorized as Class III because there were no other products like it on the market already, according to its reclassification application. The software was reclassified into a Class II device.

Clearance or approval?

Class I or II devices can get FDA clearance, while Class III devices need to obtain FDA approval to be legally marketed.

Device manufacturers often apply for the FDA’s less-burdensome 510(k) pathway for Class I and II devices, according to Zegarelli.

The process compares the new device to one already on the market and must find they are “substantially equivalent”—meaning they have the “same intended use and same technological characteristics,” according to the FDA. A device that goes through this process is categorized as FDA cleared.

“It’s not specifically approval because the FDA isn’t actually independently reviewing the safety and effectiveness of the device,” he said.

Only devices that go through a premarket approval (PMA) can say they are FDA-approved. During the PMA process, the FDA must independently prove that the device is safe and effective, and that the health benefits outweigh any risks. All Class III devices, as well as Class I and II devices that didn’t receive a “substantially equivalent” finding during the 510(k) application, must go through this process.

The PMA pathway is the most involved FDA regulatory process. The FY2023 standard fee for a PMA application is $441,547, compared to $19,870 for a 510(k), according to the FDA.

Other terms, such as “FDA granted” or “FDA authorized,” are not the same as “approved.”

Manufacturers market a device as FDA granted or authorized to signal that the device has gone through an FDA regulatory process without providing additional details, Zegarelli said. Using these terms, however, does not violate any FDA rules, he added.

The device may have gone through the De Novo pathway, according to Zegarelli, in which a novel device that was initially classified as Class III because it was not substantially equivalent to any other device on the market is reclassified at a lower level.

As much as some companies may want to use the terms “clearance” and “approval” interchangeably, the FDA is clear that approval is only for certain devices, according to Zegarelli.

“There’s always an advantage or perceived advantage from a commercial standpoint to claim that you’'re FDA approved, because it makes it sound much more important,” he concluded.