Voluntary eSTAR Pilot Program Streamlines 510(k) Preparation and Review

Today, the U.S. Food and Drug Administration (FDA) is announcing its voluntary electronic Submission Template And Resource (eSTAR) Pilot Program and is soliciting participation from 510(k) submitters.

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The pilot program aims to improve consistency and efficiency in how the medical device industry prepares premarket notifications (510(k)s) and how the FDA reviews these submissions.

eSTAR is a PDF electronic submission template that guides 510(k) submitters through the process of preparing a comprehensive medical device 510(k) submission. This free template contains:

Automation (such as form construction and autofilling)
Content and structure that is complementary to CDRH internal review templates
Integration of multiple resources (such as guidances and databases)
Guided construction for each submission section
Automatic verification (the FDA does not intend to conduct a Refuse to Accept review for the pilot).

Voluntary eSTAR Pilot Program Participation

The eSTAR Pilot Program will begin accepting statements of interest for participation on February 26, 2020. The FDA will select up to nine participants who provide a holistic representation of the medical device industry and meet the selection criteria, outlined in the Federal Register Notice. The FDA also requests feedback to targeted questions to assess the Pilot Program.

Questions?

If you have questions about this Pilot Program, contact esubpilot@fda.hhs.gov. For general questions contact the Division of Industry and Consumer Education.