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FDA Preps Device Makers To Use eSTAR For De Novo Requests

 
• By Shawn M. Schmitt

Manufacturers can’t use the US FDA’s voluntary eSTAR product submission program for de novo requests until January – but they can start practicing now on how to use eSTAR for that review pathway.

A star.

The US Food and Drug Administration is prepping medical device manufacturers on how to make de novo requests via the agency’s voluntary eSTAR product submission program.

At present, the FDA’s electronic Submission Template And Resource – or eSTAR – template is reserved for companies making 510(k)...

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