The Latest FDA Q-Submission Final Guidance

This webinar will discuss the Q-Submission program, with includes Pre-Subs, Submission Issue Requests (SIRS), Study Risk Determinations, Informational Meetings, PMA 100-Day Meetings, and other meetings and uses for Q-Sub requests.

The term "Q-Submission" or "Q-Sub" refers to the system used to track the collection of interactions described above. These are important opportunities for submitters to share information with FDA and receive input outside of the submission of an IDE, IND, marketing submission, Accessory Classification Request, or CW (CLIA Waiver). Q-Subs can serve as helpful tools in the premarket submission process and FDA reviewers work interactively with submitters while the Q-Sub is under review to maximize the benefits of this process. The interactions tracked in the Q-Sub program may be used at different points along the total product life cycle for a device and are voluntary. E.g., in a given product's development cycle, a submitter may wish to conduct an Informational Meeting, followed by a request for Breakthrough Device Designation, with later discussions to refine specific aspects of non-clinical and clinical testing through Pre-Subs. Tracking these interactions as Q-Subs facilitates review and serves to document interactions for the record.

WHY YOU SHOULD ATTEND:

This webinar discusses how to request interactions with the FDA related to medical device submissions. These include written feedback and/or a meeting 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.

AREAS COVERED:

• Get a clear understanding of the FDA Pre-Submission (Pre-Sub) process and how it strengthens your overall regulatory strategy.

• Learn the best practices for responding to Submission Issue Requests (SIRs) and avoiding common pitfalls.

• Explore the purpose and structure of the Q-Submission program and why it matters in today’s compliance environment.

• Review the different types of Q-Subs and identify which format is most effective for your submission.

• Gain insights into planning and conducting FDA Informational Meetings to maximize reviewer feedback.

• Discuss PMA 100-Day Meetings in the context of FDA requirements under 21 CFR Part 814, and understand how they can fast-track approval timelines.

• Identify regulatory interactions that fall outside the Q-Sub program but still carry significant impact on your product lifecycle.

• Learn the step-by-step Q-Sub submission process, aligned with documentation requirements under ISO 13485:2016, Clause 7.3, to ensure quality and consistency.

WHO SHOULD ATTEND:

• Quality Assurance Departments
• Regulatory Affairs Departments
• Software Programming, Documentation, Testing Teams
• Research and Development Departments
• Engineering Departments
• Production Departments
• Operations Departments
• Senior Management
• Consultants; others tasked with Product, Process, Electronic Records Software V&V Responsibilities

Course Director: JOHN E. LINCOLN

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 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 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 published 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.