The FDA is often criticized for stifling innovation and lagging device approvals. Due to this, many manufacturers are looking overseas because of these regulatory challenges by the Food and Drug Administration. According to a survey funded by the Institute for Health Technology Studies, medical device companies (263 out of 350 or 75%) are pursuing approval for their products overseas first. The difference in delay between the United States and the European Union is 1-3 years and probably because the regulatory process in EU is more efficient and predictable. Also important to note that the FDA requires evidence of safety evidence that the device performs consistently to the manufacturers use as compared to the CE Mark that only requires proof of safety. But is it always worth seeking approval overseas (for Americans)? Companies must determine their regulatory strategy to minimize their risks. In efforts of faster approval times and more predictability in Europe, a manufacturer still isn’t guaranteed that the device will be widely accepted for the physicians in the European countries. If time is of the essence, then seeking approval in Europe is the way to go but that will not guarantee overall success of the product.