The Latest FDA Q-Sub 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 should you 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 in the Session

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

Who Will Benefit

Senior Management in Devices, Combination Products
QA / RA
Software Development, Programming, Documentation, Testing Teams
R&D
Engineering
Production
Operations
Marketing
Consultants; Others tasked with Product, Process, Electronic Records Software V&V Responsibilities

Speaker Profile

John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.

John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.