[url=https://www.i3cglobal.com/fda-510k//]FDA 510(k) Clearance![/url] is a premarket submission made to the US Food and Drug Administration (FDA) to demonstrate that a medical device is safe and effective. This clearance is required for devices that do not need to go through the more rigorous Premarket Approval (PMA) process.

The [url=https://www.i3cglobal.com/fda-510k-submission/]510(k) submission![/url] must show that the new device is substantially equivalent to a legally marketed device, known as a predicate device. The FDA reviews the submission to determine if the new device is as safe and effective as the predicate device. If the FDA determines that the device meets the criteria, it grants 510(k) clearance, allowing the device to be marketed in the United States.

It's important for manufacturers to carefully prepare their 510(k) submissions, providing detailed information about the device, its intended use, and how it compares to the predicate device. This process can be complex and requires a thorough understanding of FDA regulations and guidelines.

Overall, FDA 510(k) Clearance is a crucial step in bringing a new medical device to market, ensuring that it meets the FDA's standards for safety and effectiveness.

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