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The Latest FDA Q-Submission Final Guidance

This course helps professionals structure FDA Q-Submission interactions more effectively, improving submission readiness, reviewer communication, and regulatory planning across the medical device product lifecycle. It supports stronger decision-making for Pre-Subs, SIR responses, Informational Meetings, and PMA-related discussions. This Course is designed for professionals responsible for FDA submission planning, quality documentation, regulatory coordination, and product development activities.

REGISTER FOR THE COURSE

US $190 per learner

30-Days Unlimited Streaming Access

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REGISTER FOR THE COURSE

To Get 30-Day Access to ONLY this Course 

US $190 per learner
  • This course is Included in Subscription Pack
Subscription include access to entire Learning Library
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  • Instructor : John E. Lincoln ‎ 
  • Study time : 90 Minutes
  • Skill Level: Intermediate
  • Course ID: TF3257
  • Assessment & Certification Included
  • Ask the Expert

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About the Course

FDA’s Q-Submission program provides structured pathways for obtaining agency feedback before or during critical stages of medical device development and review. Pre-Subs, Submission Issue Requests (SIRs), Informational Meetings, PMA 100-Day Meetings, and related interactions influence how sponsors address clinical, non-clinical, and regulatory expectations before formal decisions are made. Effective use of these interactions can reduce uncertainty, clarify testing approaches, and strengthen submission quality across IDEs, PMAs, 510(k)s, De Novo requests, CLIA Waivers, and selected CBER-regulated submissions.


Current FDA expectations require organizations to manage Q-Sub communications with clear documentation, consistent follow-up, and well-defined regulatory objectives. This course explains the structure and operational use of the Q-Submission program, including the distinctions between interaction types and their role throughout the device lifecycle. It also addresses submission preparation practices connected to ISO 13485:2016 Clause 7.3 and FDA meeting processes under 21 CFR Part 814.

  • Strengthen FDA Interaction Planning:

    Participants will gain practical understanding of how different Q-Submission pathways support regulatory communication throughout device development and review. The course clarifies when to use Pre-Subs, SIRs, Informational Meetings, and PMA 100-Day Meetings, helping organizations prepare focused questions, reduce avoidable review delays, and document interactions more consistently as regulatory expectations continue to evolve.

  • Improve Submission Readiness and Documentation Control:

    The course provides operational insight into preparing Q-Sub requests and managing supporting records in alignment with FDA expectations and ISO 13485:2016 Clause 7.3 requirements. Participants will better understand how structured regulatory interactions contribute to stronger submission planning, more effective reviewer engagement, and improved coordination between quality, clinical, and regulatory functions during product development activities.

Key Areas Covered

  • Structure and purpose of the FDA Q-Submission program across the medical device product lifecycle
  • Operational use of Pre-Submissions, Submission Issue Requests (SIRs), Study Risk Determinations, and Informational Meetings
  • Regulatory interactions associated with IDEs, PMAs, HDEs, De Novo requests, 510(k)s, CLIA Waivers, and selected CBER submissions
  • Planning and conducting FDA Informational Meetings to obtain meaningful reviewer feedback and clarify submission expectations
  • PMA 100-Day Meetings and their regulatory context under 21 CFR Part 814
  • Q-Submission preparation practices aligned with ISO 13485:2016 Clause 7.3 documentation requirements
  • Best practices for responding to FDA feedback during Q-Sub review interactions to support efficient submission progression
  • Regulatory interactions outside the Q-Submission program that may still significantly affect product development and approval activities

Who Must Attend

  • QA/QC Departments
  • Research and Development Teams
  • Engineering Departments
  • Regulatory Affairs Departments
  • Production Departments
  • Operations Departments

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

JOHN E. LINCOLN

John E. Lincoln, Principal of J. E. Lincoln and Associates LLC, has more than 36 years of experience in FDA-regulated industries, including 22 years as an independent consultant. His work includes regulatory affairs, FDA responses, 510(k) submissions, quality systems remediation, design controls, validation activities, and risk management documentation. He has supported organizations ranging from start-ups to Fortune 100 companies and has conducted international workshops and webinars focused on FDA submissions, compliance, and quality system requirements.

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Ready to Strengthen Your Team? Let’s Build Your Training Plan.

Whether you’re looking for a single onsite workshop or a multi-team training series, we’ll help you design a program that fits your goals, timelines, and operational reality.

Your team deserves the clarity.
Your organization deserves the confidence.

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Our students love us ❤️

“Didn’t feel overloaded with regulatory language. The examples tied back well to normal submission planning activities.”


Production Supervisor

“Helpful refresher on
Q-Submission interactions and related documentation expectations. Covered the important points without overdoing it.”

Quality Systems Manager

“Presenter kept the discussion focused and organized. The feedback and follow-up session was useful for our group.”


Regulatory Affairs Specialist

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