FDA eSTAR General Overview – Live-Stream, May 23, 2025 @ Noon-1pm ET (Free Template) Everyone asks how much a 510(k) costs and how long it takes: https://youtube.com/live/K0WfqbB5-r8 - how much does it cost? https://youtu.be/e6cNlWN_K6U - how long does it take? But today you are going to learn how the FDA eSTAR works and the basic steps to complete one. The eSTAR is an Adobe Acrobat Pro template that was created by the FDA, and it is password protected to restrict edits. Instead of creating an FDA eCopy, now we just upload a single PDF file. Every 510(k) and De Novo must be submitted using the eSTAR template. This ensure every company uses the same format and 100% of submissions include the required content. If you are filling in the FDA eSTAR for the first time, we created a 1-page flowchart explaining how to complete your 510(k). The flowchart includes references to each template you need and when each task in the flowchart should be done. Every eSTAR should begin with the creation of a detailed device description and answering the eSTAR questions about your device's indications for use, classification, and technological characteristics. Your answers determine which sections of the eSTAR need to be completed and which sections are not applicable. If you answer any of the questions incorrectly, your submission will be missing information and the FDA will reject your submission in the first 15 days during their technical review.