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:

• The Pre-Sub
• The SIR
• The Q-Submission
• Types of Q-Subs
• Informational Meetings
• PMA 100-Day Meetings
• Outside the Q-Sub Program
• The Q-Sub Submission Process

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.