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    eSTAR

    FDA's interactive PDF template for preparing and submitting 510(k) and De Novo submissions.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    eSTAR is a guided, structured submission template that performs automated content checks. It is mandatory for 510(k) submissions and supported for De Novo submissions to FDA's CDRH.

    What this means in practice

    Using eSTAR eliminates the Refuse-to-Accept (RTA) review for 510(k)s and forces complete, well-organized content. Vendors increasingly build internal tools that map QMS records to eSTAR sections.

    Cross-references

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    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    FDA·2RAPS·1
    1. 1
      eSTAR Program
      Verified
      FDAfda.gov
    2. 2
      RAPS Regulatory Focus
      Verified
      RAPSraps.org
    3. 3
      FDA - Medical Devices
      Verified
      FDAfda.gov

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