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[FDA News] New Announcement: You Can Now Opt to Use eSTAR for 513(g) Information Requests

Date: 4/1/2024

eSTAR 513(g)

Great news! Starting March 29, 2024, you can choose to use eSTAR for your 513(g) requests for information to CDRH. But what exactly is eSTAR?


eSTAR, short for electronic Submission Template And Resource, is a handy interactive PDF form designed to guide you through the process of preparing your medical device submission. Here's why it's awesome:


  1. It helps you make sure you're providing all the necessary details for your submission.

  2. It aligns with the reviewer's SMART template, making sure they get the information they need.

  3. It's standardized, making it easy for both you and the reviewer to access and understand the information.

  4. It automates many parts of the submission process, reducing the chance of a Refuse to Accept review.

  5. It saves you time by automatically filling in repeated information.

  6. It includes built-in databases to ensure accuracy in device-specific guidelines and standards.

  7. It comes with handy built-in forms, like Truth & Accuracy statements and Declarations of Conformity.

  8. It collects submission data in a structured format, making it easier for the FDA to process.

Best of all, eSTAR is completely free! While it's required for most medical device submissions, it's also available for voluntary use for other submissions like 513(g) requests.

Using eSTAR not only makes your submission process smoother but also helps ensure that your device gets the timely review it deserves. So, why wait? Give eSTAR a try for your next submission and experience the difference!


For more details, please click below link.


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