FDA Updates eSTAR Portals for De Novos, 510(k)s

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FDA Updates eSTAR Portals for De Novos, 510(k)s

Dennis Tosh

November 29, 2021 at 03:15 PM EST

The FDA Nov. 29 updated its electronic Submission Template and Resource (eSTAR) portals for de novo classification request and premarket notification (510(k)) submissions. The update included a revamping of the agency’s premarket submission webpage to make the online information available there easier to find. eSTAR is an electronic submission template built within a structu... Read More

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