FDA Registered, Approved, Cleared: What’s the Difference?

Ever wondered what it means when someone claims that a medical product or device is "FDA Approved" or "FDA Registered"? Don't worry, you're not alone – here's what you should know. 

The FDA 

The Food and Drug Administration (FDA) is the US government agency responsible for safeguarding public health. It helps to determine the safety and suitability of various products coming to market, including medical devices. 

If a company wants to sell a medical device in the US market, the FDA places the product into one of three categories depending on how "risky" it is for someone to use them. The risk categories are:

• Class I: Very low-risk items such as bedpans and bandaids.

• Class II: Medium-risk devices, including contact lenses, syringes, and pregnancy test kits.

• Class III: These items pose the highest risk to a patient's health and include, for example, implants and ventilators.

But what do these classifications have to do with whether something's FDA Approved, Registered, or Cleared? Well, let's take a look. 

FDA Registered

To be clear, all medical devices sold in the USA must be registered with the FDA, or "FDA Registered." So, even a Class I medical device must be FDA Registered. 

• If a device is only FDA Registered, the manufacturer cannot claim that it's Approved or Cleared. Why? Because the FDA hasn't actually determined whether it's fit for purpose or not, only that it's a low-risk product.

• Class I, FDA Registered devices won't have an FDA label.

FDA Approved

Some devices, such as Class III devices, need FDA Approval before coming to market. 

• To secure FDA Approval, a manufacturer must show that the device is effective and safe for use.

• The manufacturer must have sufficient evidence available to support their claims.

FDA Cleared

FDA Cleared status generally applies to Class II devices. These devices are subject to some regulatory oversight, but they don't need to be formally tested and approved the way Class III devices must be. 

• Class II devices are "cleared" to go to market if they're substantially similar to another Class II device in the US marketplace.

• These devices cannot be marketed as FDA Approved, and manufacturers can't use FDA marketing or labeling on the device.

So, just because a device is "FDA Cleared" doesn't mean it's fit for the intended use, and it hasn't been rigorously tested by the FDA for safety purposes.

Want to check if a device is FDA Registered? Check thehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm