New FDA Guidance Offers Additional Info On eStar Submissions
Executive Summary
The US Food and Drug Administration says its guidance for manufacturers seeking premarket clearance is part of the agency’s overall commitment to improve e-submission consistency and enhance the review process.
You may also be interested in...
US FDA Finalizes Medical Device Electronic Submissions Guidance
The guidance document explains the history of and requirements for electronic submissions of 510(k)s.
FDA Finalizes Electronic Submissions Guidance
The guidance document explains the history of and requirements for electronic submissions of 510(k)s.
FDA Preps Device Makers To Use eSTAR For De Novo Requests
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.