What Is FDA Clearance?
FDA clearance refers to the U.S. Food and Drug Administration regulation of medical devices. Medical devices represent just one area of production and sale regulated by the FDA, but they are the only items that may receive clearance. Other areas of FDA jurisdiction include drugs, dietary supplements, cosmetics, vaccines, and food.
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510k
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Products are cleared with the FDA by filing a 510k form. This form must be approved by the FDA before the medical devices can be sold to the public.
Applicability
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FDA clearance is not the same as FDA approval. Whereas completely new devices are approved, devices that have only slightly modifications of already approved devices are cleared.
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Requirements
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To receive clearance, a new medical device must serve the same purpose as an existing and approved device and have no fundamental differences in how it achieves its objective. By showing that a device works effectively in the same manner as a device that is already approved, the device is indirectly shown to meet the FDA's standards for safety and effectiveness.
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