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New FDA Guidance Offers Additional Info On eStar Submissions

 
• By Brian Bossetta

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.

FDA LAPTOP.
• Source: Alamy

The US Food and Drug Administration issued a draft guidance document on 29 September to update device makers on the agency’s eSTAR (electronic Submission Template And Resource) program for electronic 510(k) applications to the agency’s devices and biologics centers.

In 2017, Congress directed the FDA to create and publish standards for electronic submissions. The agency’s first move in the 510(k) e-submissions space was 2018’s Quality in 510(k) (QUIK) pilot...

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