What is the Difference between FDA 510k Clearance and Approval?
As a medical device professional, you know how difficult it is to get your product on the market. It can be difficult to determine your device classification, even though it seems simple.
After you have determined the classification, you will still need to make the difficult decision about which regulatory submission route you want. It can take months or even years to develop a product and prepare all documentation necessary for submission.
Did you know that FDA gives specific terminology to devices submitted for review?
Most likely, you have heard the terms Clearance and Approval and Granted many times in the medical device industry.
You may believe that these terms are the same. You may have heard them interchangeably, so you thought it was not a big deal to use one over the other.
This couldn’t have been more wrong.
It is important to use the right terminology. Worst case scenario, incorrect use of terminology can have serious legal consequences for you and your company.
Companies need to distinguish between these terms and when they are appropriate. Let’s take a closer look at Clearance vs approval vs granted.
WHAT DIFFERENCE IS THERE BETWEEN CLEARANCE AND APPROVAL?
Although you may believe I am arguing semantics, FDA is clear the terms Clearance and Approval refer to distinct processes in different pathways of bringing medical devices to market.
- 510(k) Clearance: A medical device that has been cleared has had to undergo a 510(k), which FDA has reviewed and has provided Clearance.
- 510(k) Approval – Class III medical devices must be approved and reviewed before legally being marketed. After submitting a premarket application (PMA), or a Humanitarian Device Exemption, the FDA will approve the device.
- Grant: Before medical devices can legally be sold in the United States, they must have been granted by FDA. This term is relatively new in the FDA lexicon.
For example, take the Apple Watch. It has attracted media attention because it was FDA cleared as a Class II medical device. The FDA does not approve Class II or Class I devices. It only grants Clearance.
Jon Speer spoke out on the subject during a recent interview published by The Verge. “Class I and Class I products are lower-risk products. A classic Class I example is like a tongue depression — it’s easier to get Clearance than approval.
This misuse of terminology can also be seen in media, where the three terms are used interchangeably and imprinted in our minds to confuse us later. You’ll find press releases or blog posts from large, well-known medical devices companies stating that their 510(k) was “approved.”