What does NSE indicate regarding a device submitted for evaluation?

Not Substantially Equivalent (NSE) is a designation given by the FDA during the 510(k) premarket notification process when a device is evaluated and found not to meet the criteria of substantial equivalence to an already marketed device. This means that the FDA has determined that there are significant differences in safety or effectiveness between the proposed device and the predicate device that was identified in the submission.

The outcome of NSE indicates that the product cannot be marketed based on its 510(k) submission, and the manufacturer may need to pursue a different regulatory pathway, such as the premarket approval (PMA) process, which is more rigorous and requires clinical data to support safety and effectiveness. Thus, recognizing NSE is critical for manufacturers in understanding the regulatory standing of their device and the necessary steps for obtaining approval.