A recent survey of almost 200 med-tech executives measured the perceptions of the 510(k) pathway, FDA’s performance, and FDA’s consistency. While FDA continues to try and clarify the pathway for approval, there continues to be much controversy and confusion of the direction of the program. This is in stark contrast to FDA’s goal of 510(k) which is to provide predictability for companies seeking lower-risk device approval. So, what did the recent survey show?