At the completion of a review of a 510(k), what action may the FDA NOT take?

The correct action that the FDA may not take at the completion of a 510(k) review is to approve the device for market. This is because the 510(k) process is not an approval process but rather a determination of substantial equivalence. The FDA's role in reviewing a 510(k) submission is to assess whether the new device is substantially equivalent to an already legally marketed device.

When a manufacturer submits a 510(k), they are seeking a determination from the FDA that the new device is as safe and effective as a predicate device. If the FDA finds that the device is substantially equivalent, it can declare this outcome. Conversely, if the device is found to not be substantially equivalent, the FDA can declare it as such, potentially leading to the need for more clinical data or a different regulatory pathway.

In some cases, the FDA might determine that a 510(k) is not required for a device, indicating that it does not fall under the regulatory purview typically requiring such a submission. However, approval for market access is reserved for Class III devices that undergo the Premarket Approval (PMA) process, which is distinct from the 510(k) process. Thus, while the FDA may take other actions like declaring substantial equivalence