If FDA declares a device as Not Substantially Equivalent (NSE), what is the first option a company should consider?

When the FDA declares a device as Not Substantially Equivalent (NSE), the most logical first step for a company is to resubmit a premarket notification (510(k)) with new data. The NSE determination typically indicates that the information provided in the initial submission did not demonstrate that the new device is at least as safe and effective as a legally marketed predicate device.

By resubmitting a 510(k) with additional or revised data, the company can address the deficiencies noted by the FDA. This can include providing more comprehensive clinical data, enhanced manufacturing information, or other supporting materials that clearly demonstrate the device’s equivalency to an existing product. Resubmitting allows the company to take direct feedback from the FDA into account, potentially leading to a more favorable review outcome.

In contrast, filing a Premarket Approval (PMA) immediately can be a more complex and lengthy process that is often not necessary or appropriate immediately after an NSE determination, and petitioning for downclassification may not be applicable if the device doesn't meet the criteria for a lower risk classification. Submitting for approval in Europe also diverts focus from addressing the specific issues raised by the FDA regarding the device's current status in the U.S. market.