The electronic Submission Template And Resource (eSTAR) is a great aid for medical device submissions to the U.S. Food and Drug Administration (FDA). The eSTAR is “an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device submission” (https://www.fda.gov/medical-devices/how-study-and-market-your-device/estar-program). However, the form can lull submitters into unduly delayed cybersecurity work....Read More