Approved vs. Cleared Medical Devices: Where the FDA Draws the Line

Aug 12, 2019

By Gilreath & Associates

For those who use medical devices, the Food and Drug Administration (FDA) rating system is crucial and can be life-changing. Whether or not the FDA approves a product can bring great relief or dash hopes. This begs the questions:

What is the difference between FDA approved and FDA cleared?

The gap between cleared vs. approved is bigger than people would like to believe. It’s a popular topic right now and was even featured on the LastWeekTonight show with John Oliver.

What does FDA “cleared” mean?

More than 80 percent of the medical devices in the United States are FDA cleared, which means they go through a simple testing process.

What is FDA “approved”?

The bar is set much higher for medical devices that have been FDA approved vs. cleared, meaning they’ve been through numerous and more strenuous tests to ensure they work.

FDA medical device testing processes

Before the FDA approves or clears any medical device, it must go through one of these processes:

Premarket notification [510(k)]

This means makers must prove the device is equivalent to a device already placed into Class I (minor risk medical device) or Class II (moderate risk) before it’s allowed into the U.S. market. Some devices are exempt from a 510(k) but must still be listed with the FDA.

Premarket approval (PMA)

All Class III devices are required to go through this process. They must demonstrate that they are safe and effective to use. More rigorous than a 510(k), this means devices like these are more strongly tested.

Humanitarian Device Exemption (HDE)

A Humanitarian Use Device (HUD) is eligible for this exemption and is intended to be used by individuals affected by a disease or condition that affects 8,000 individuals or less per year in the United States.

Always ask your doctor

Some doctors don’t even know whether certain medical devices are cleared versus approved because they assume the FDA has already given those devices the green light. If you’ve been recommended for one, remember to ask your doctor about the risks and whether it’s been cleared or approved.

This can be confusing for consumers, so we’re ready to help provide guidance and expertise in this area. If you or a loved one have been injured by a defective medical device, contact the Tennessee personal injury lawyers at Gilreath & Associates today to schedule your free consultation.

External Resource: MedWatch Safety Alerts

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