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JNM Global/Medical Device

Updated Guidance on eSTAR submissions

JNM Global 제이엔엠글로벌 2023. 4. 11. 13:20

 

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