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Five Tips to the FDA eSTAR Application Submission Process | |
The electronic Submission Template and Resource (eSTAR) is an FDA submission tool that guides applicants through the process of preparing a medical device submission. It is free and available for voluntary use by anyone wishing to submit 510(k)s and De Novo requests to the Center for Devices and Radiological Health (CDRH) or the Center for Biologics Evaluation and Research (CBER). Simply an interactive PDF form, the eSTAR, is designed to improve consistency and enhance efficiency in the FDA review process through automation, integration of resources, and current FDA guidances. It also helps in constructing each submission section to align with the content of the FDA 510(k) review memo template. As the application is automatically verified for completion, the FDA does not intend to conduct a Refuse to Accept (RTA) review for eSTAR submissions which will also help to speed up the review process. Starting October 1, 2023, all 510(k) submissions, unless exempted, must be submitted electronically using eSTAR. Now is the perfect time to get familiar with the eSTAR application and the following article offers five tips to keep in mind when using the application for the first time. For more details please visit our website - https://www.medhealthreview.com/2025/03/27/five-tips-to-the-fda-estar-application-submission-process/  | |
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| Target State: New York Target City : New York City Last Update : Oct 23, 2025 6:54 AM Number of Views: 33 | Item Owner : medhealthreview Contact Email: (None) Contact Phone: (None) |
| Friendly reminder: Click here to read some tips. | |
USNetAds > Health & Beauty > Health Services > Item ID 130639578
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2025-10-23 (0.577 sec)