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JALEX Medical: FDA Cleared or Approved? That is the question…

by Dana Foster6. March 2013 11:44

I always hear people say “XYZ Company got their medical device approved by the FDA”.
But was the device approved or cleared for market? What’s the difference one might ask? It’s
all in the name of the application and class the device falls under. For instance, if you have a
Class II device, a 510k submission is required. After review, the FDA will provide you with
a “clearance” letter allowing the company to market the device. The FDA does not “approve”
Class II devices. They simply review your application and either agree or disagree that you have provided enough information that your device is substantially equivalent to another device on the market.

However, the FDA does “approve” Class III devices submitted in a PMA (Premarket
Approval) application. Class III devices are typically new and novel with no other device on
the market to compare with. The application requirements and review process are much more
extensive and the device will be considered “approved” by the FDA once complete.

Need more information? Check out JALEXMedical.com or contact one our employees.


Written By: Jennifer Palinchik


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