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Validity : 28th Jun'25 to 08th Jul'25
The Latest FDA Q-Sub Final Guidance
- The Q-Sub Program – Final Guidance
- The Process
- The Pre-Sub
- Types of Q-Submissions
- SIR, Study Risk Determinations, Informational, PMA
- Basic Content / Checklists
- E-Submission Format and Content
Overview of the webinar
This webinar will discuss the US FDA’s Final Guidance on the Q-Submission Program, dated May 29, 2025, which addresses how to request interactions with the FDA related to future medical device submissions. This allows companies and the FDA to arrive at mutual understanding of a project’s approach, FDA concerns, and ultimate buy-in by both parties wherever possible.
Who should attend?
- Top management
- R&D
- Engineering
- Marketing
- Regulatory Affairs
- Clinical
- QA
- Manufacturing
- Operations
- Staff
Why should you attend?
These meetings can include written feedback and/or a meeting(s) with FDA on: Investigational Device Exemption (IDE) applications, Premarket Approval (PMA) applications, Humanitarian Device Exemption (HDE) applications, Evaluation of Automatic Class III Designations (De Novo requests), Premarket Notification (510(k)) submissions, Clinical Laboratory Improvement Amendments (CLIA) Waiver by Applications (CW), Dual 510(k), Accessory Classification Requests, and certain Investigational New Drug Applications (INDs) and Biologics License Applications (BLAs) submitted to the Center for Biologics Evaluation and Research (CBER)) (specifically, INDs and BLAs for devices that are regulated as biological products. Such Q-Sub meetings may be conducted in-person or virtually (by videoconference or teleconference). Some other submission types are tracked with a “Q” number and should be submitted following the processes for Q-Subs, per other guidance documents. There are also other interactions with FDA that are outside the scope of the Q-Sub program.
Faculty - Mr.John E. Lincoln
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 40 years experience in U.S. FDA-regulated industries, 27 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has ptublished numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.