The FDA eSTAR Program

 

The FDA eSTAR Program was developed to improve efficiency and consistency in preparing and reviewing 510(k), De Novo, and PMA submissions by the U.S. Food and Drug Administration. Building on the earlier eSubmitter approach for electronic medical device and IVD submissions, the eSTAR program reflects the FDA’s accumulated regulatory experience. It originated from the Electronic Submission Template and Resource (eSTAR) Pilot Program. Since October 1, 2023, 510(k) submissions require eSTAR, and De Novo submissions (unless exempt) will require eSTAR from October 1, 2025. Templates are available online and require FDA account credentials for submission.

What is FDA eSTAR?
eSTAR is an interactive PDF template designed to support the preparation of comprehensive medical device pre-market submissions. It also enables applicants to respond to FDA requests for additional information. The system enhances submission quality by ensuring the inclusion of complete and high-quality data for regulatory review.

By adopting eSTAR, submitters can ensure submission completeness, enabling more efficient pre-market reviews and timely access to safe and effective medical devices. The template is free and supports 510(k), De Novo, and voluntary Q-submissions and PMA 30-Day Notice supplements. Two template types exist: medical devices and IVDs. PreSTAR beta has evolved, and applicants should use the latest Q-submission templates via the CDRH Customer Collaboration Portal (CCP). The eSTAR 6.0 template for non-IVD De Novo/510(k) was released in October 2025.

Characteristics and Limitations
eSTAR offers structured, interactive forms for medical device and IVD submissions, along with defined benefits and limitations that applicants should evaluate before adoption.

Considerations for Effective Usage

  • Automated integration of regulations and standards
  • Guided section-by-section submission structure
  • Reduced manual data entry and human error
  • Recommended tools: Adobe Acrobat Pro or Foxit PDF Editor
  • Integrated forms: Form 3514 and Form 3881
  • Support for Excel and MP4 attachments
  • Macro-enabled and executable files not allowed
  • Maximum size: 1GB (files over 4GB rejected)
  • Large submissions may be mailed to the Center for Devices and Radiological Health Document Control Center (DCC)

Best Practices

  • Follow FDA guidance
  • Ensure complete information
  • Maintain submission consistency
  • Provide clear and concise content
  • Verify data accuracy to prevent deficiencies

 

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