Which of the following is not an option available to an applicant if a device is deemed NSE?

When a device is deemed Not Substantially Equivalent (NSE) in response to a 510(k) application, the applicant has several potential avenues for further action. However, submitting a Premarket Approval application (PMA) immediately is not one of the options.

A PMA is typically required for devices that are classified as Class III, which generally involves a more rigorous approval process focused on demonstrating safety and efficacy through clinical data. If a device has been ruled NSE, it indicates that it does not meet the necessary criteria for substantial equivalence to a predicate device. This status does not allow the applicant to bypass the regulatory process to submit a PMA directly; instead, the applicant must identify and pursue an appropriate pathway, such as gathering new evidence for reconsideration or exploring reclassification options.

On the other hand, options like requesting a Class I or II designation through the de novo process, resubmitting another 510(k) with new data, or filing a reclassification petition are viable alternatives that allow the applicant to either seek a new classification for the device or resubmit their application with additional information. These avenues provide a structured route to potentially navigate around the NSE determination by either demonstrating equivalency with other devices or adequately justifying the device's