510(k) Modernization, Breakthrough Device, and Safer Technologies Programs (STeP)

  • Instructor : John E. Lincoln
  • Level : Intermediate
  • Study time : 87 minutes
  • Course ID: TF3659
  • Included in Subscription Pack
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ABOUT THE COURSE

Want faster FDA clearance for your breakthrough device?
Not sure how to leverage the STeP or Breakthrough program?
Struggling to align with the modernized 510(k) pathway?


This course gives you the updated playbook on FDA's accelerated pathways for safer, smarter technologies and how to use them effectively.


WHAT WILL YOU GAIN
  • Complete clarity on the Breakthrough and STeP programs
  • Strategies to use beneficial iteration in your 510(k)
  • Confidence in meeting FDA expectations pre- and post-submission


WHY TAKE THIS COURSE
  • Fast-track your device without sacrificing safety or compliance
  • Apply FDA's latest modernization strategies to your advantage
  • Make smarter submission choices from day one


KEY AREAS COVERED
  • Medical Device Safety Action Plan and 510(k) modernization
  • Breakthrough and Safer Technologies Programs (STeP)
  • Beneficial Iteration within the 510(k) framework
  • Draft guidance and real-world applications of STeP
  • Q-Submissions and pre-submission strategies
  • Aligning with FDA expectations across the submission process

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

JOHN E. LINCOLN

John E. Lincoln is a leading FDA compliance expert and founder of J. E. Lincoln & Associates. With 36+ years of hands-on experience across regulatory affairs, quality systems, 510(k) submissions, and technical file development, he's helped global firms navigate changing FDA expectations. He's a trusted name in the medical device space for breakthrough and safer technology approvals, and frequently advises on modern submission frameworks. A published author, speaker, and longtime industry columnist, John brings unmatched depth and clarity to complex regulatory shifts.

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