You can no longer approach the FDA without an eSTAR. To launch a medical device in the U.S., entering the FDA’s gateway is an absolute necessity. For most companies, the preferred route is the 510(k), or Premarket Notification process. While primarily designed for Class II (moderate-risk) devices, it also applies to certain low-risk or high-risk devices depending on their unique technical characteristics. In fact, the vast majority of medical devices entering the U.S. market