The US Food and Drug Administration issued a draft guidance document on 29 September to update device makers on the agency’s eSTAR (electronic Submission Template And Resource) program for electronic 510(k) applications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.
New FDA Guidance Offers Additional Info On eStar Submissions
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.
