Final answer:
The most practicable first option for a company after a device is declared Not Substantially Equivalent (NSE) by the FDA is to resubmit a 510(k) application with new data proving the device's safety and effectiveness. This allows addressing FDA's specific concerns while avoiding the more rigorous PMA process.
Step-by-step explanation:
When the FDA determines a device from a 510(k) application to be Not Substantially Equivalent (NSE), it implies that the device cannot be marketed because it is not considered equivalent to any legally marketed predicate devices. In such a scenario, the most practicable first option for a company is to resubmit a 510(k) with new data to demonstrate that the device is at least as safe and effective as the predicate. This course of action allows the company to address specific concerns raised by the FDA during the initial review and provides an opportunity to stay within the 510(k) framework, which is generally less expensive and faster than the PMA process.
Filing a Pre-Market Approval (PMA) is often more time-consuming and costly, as it involves a more thorough review process that includes the submission of extensive clinical data to demonstrate safety and effectiveness. On the other hand, petitioning the Center for Devices and Radiological Health (CDRH) to downclassify the device or submitting the product for approval in Europe are alternative options, but these pathways may not necessarily address the FDA's concerns about the device's equivalence to a predicate.