FDA 510(k) reviews.

Access to the US medical market

Your medical device has the same intended use and many physical and performance similarities (or nearly) with a medical device that has already been admitted to the US market. In that case, you can obtain access to the US market from the Food and Drug Administration (FDA) by following the so-called 510(k) process.

KEMA is one of the third parties with permission to implement this 510(k) process on behalf of the FDA. The biggest advantage of this is that the 510(k) process via KEMA is faster than via the FDA itself. This means your time to market is weeks – and sometimes even months – shorter. KEMA’s 510(k) reviews offer you even more advantages: 

• All your testing and certificates at one institute: You can call on KEMA for 510(k) and ISO 13485
• You can deliver your products in Europe
• KEMA can simultaneously take care of approval for the US and the European markets 
• You have a local contact person.         

More information? Contact us.

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