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

• 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