Guidelines for eSTAR submissions updated on March 29, 2023.
The eSTAR is a PDF form for the process of preparing a medical device submission.
This template contains:
- Automation (for example, form construction and autofill)
- Content and structure that is complementary to CDRH internal review templates
- Integration of multiple resources (for example, guidances and databases)
- Guided construction for each submission section
- Automatic verification
Send eSTAR premarket submissions online through the CDRH Customer Collaboration Portal (CDRH Portal).
Starting October 1, 2023, all 510(k) submissions, unless exempted*, must be submitted as electronic submissions using eSTAR
For more information, please refer to the link below.
Refer from https://www.fda.gov/medical-devices/how-study-and-market-your-device/voluntary-estar-program
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