Monday, May 15, 2023

 US FDA's New eSTAR Electronic Submission Portal:

eSTAR is the new FDA electronic submission program for 510(k)'s, etc.:

https://www.fda.gov/medical-devices/how-study-and-market-your-device/voluntary-estar-program

Mandatory as of Oct 01, 2023 for 510(k)s:

https://www.fda.gov/medical-devices/how-study-and-market-your-device/voluntary-estar-program#voluntary 

-  jel@jelincoln.com

Corrected eSTAR, 01/21/24 JEL

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