The eSTAR Submission Program For 510(K)S, IDES, DE NOVOS, PMAS, And Q-Submissions

  • Instructor : John E. Lincoln
  • Level : Intermediate
  • Study time : 106 minutes
  • Course ID: TF3559
  • Included in Subscription Pack
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ABOUT THE COURSE

Are you still preparing FDA device submissions using outdated templates?
Do you fully understand the eSTAR requirements now mandatory for 510(k)s?
Is your team ready to handle AI, cybersecurity, and STeP features in submissions?


This course breaks down the FDA’s new eSTAR submission structure and helps you navigate current mandates and upcoming transitions for every major device application pathway.


WHAT WILL YOU GAIN
  • Clear guidance on using the eSTAR template for compliant 510(k) submissions
  • Knowledge of what’s next for IDE, De Novo, PMA, and Q-Sub e-submissions
  • Insight into FDA’s expectations on cybersecurity, AI/ML, and digital health features


WHY TAKE THIS COURSE
  • The eSTAR format is now mandatory for 510(k)s and expanding fast
  • Small errors in formatting or content will delay or derail your submission
  • This course shows you how to keep your files audit-ready from day one


KEY AREAS COVERED
  • FDA's eSTAR program and its impact on 510(k), IDE, De Novo, and PMA pathways
  • Structure and content of the 510(k) eSTAR submission template
  • Understanding the Parent eSTAR Guidance and future device templates
  • Cybersecurity and AI considerations in FDA device reviews
  • Q-Sub, STeP, and Breakthrough program overlaps with eSTAR
  • Post-market expectations and integrating risk-based documentation

Quality training, expert insights, and answers that matter. Know your Expert

John E. Lincoln

John E. Lincoln brings over 36 years of hands-on FDA regulatory experience, guiding companies from startups to global giants through complex submissions. He’s led successful 510(k)s, tackled tough QMS remediation projects, and authored expert-level risk management systems. If you want your eSTAR submissions to be bulletproof, he’s the consultant you want in your corner.

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