A FDA 510k Clearance, also called a 510(k) Premarket Notification, is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval.

The business submitting the 510(k) compares and contrasts the subject and predicate devices, explaining why any differences between them should be acceptable. Human data are usually not required for a 510(k) submission but this determination is made by the FDA. Laboratory testing is almost always a requirement. Depending on the type of 510(k), the law gives the FDA either 30 or 90 days to clear the device, ask questions, or reject the application.

Manufacturers may also submit a 510(k) if they alter their device. Not all changes require a 510(k) submission. In general, changes to a device’s intended use, contraindications, or basic operation require a new 510(k) clearance. Changes to blood-contacting materials, sterilization method, or performance specifications may also require a new 510(k).

The FDA does not “approve” 510(k) submissions. It “clears” them. It is not legal to advertise a 510(k) cleared device as “FDA-approved.”

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