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  • Psephos

FDA electronic submission reminder

Are you about to make a 510(k) submission to the US Food and Drug Administration (FDA)? Then don’t forget that from 1st October 2023 use of the electronic Submission Template and Resource (eSTAR) and CDRH Portal are required, unless exempted.

Psephos can provide guidance on 510(k) electronic submissions, so please contact us at for advice.



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