The submission process to the FDA can be a stressful and uncertain time for a medical device company. Delays in bringing a device to market can result in substantial revenue losses, sometimes amounting to millions of dollars. This stress is compounded by changes to standards, new guidance documents, and review variability. The FDA pre-submission process, however, can help mitigate these challenges by providing clarity and answers related to your specific device.
In this informative webinar, hosted by Thor Rollins and Matthew Jorgensen, PhD, DABT, we will delve into the intricacies of the FDA pre-submission (Q-Sub) process. Attendees will gain a comprehensive understanding of what a pre-submission meeting is and how it can significantly benefit their FDA submission strategy.
Key topics covered in this session will include:
- Understanding Pre-Submission Meetings (Q-Subs): Learn what a pre-submission meeting entails and how it can be used to gain valuable feedback from the FDA on your device before the formal submission.
- Initiating a Q-Sub: Step-by-step guidance on how to set up a Q-Sub meeting with the FDA. This will cover the initial steps, required documentation, and submission timelines.
- Preparing and Delivering Your Plan: Tips on how to prepare for the meeting, including how to present your plan effectively and ensure all necessary information is communicated clearly.
- Meeting Flow: Insights into the typical flow of a Q-Sub meeting, including what to expect and how to navigate the discussion.
- Challenging the FDA: Understanding when and how you can challenge the FDA’s feedback or requests, ensuring a collaborative and productive dialogue.
- Maximizing the Q-Sub: Strategies for getting the most out of the pre-submission process, ensuring your questions are answered and your submission is as strong as possible.
By the end of this webinar, participants will be equipped with the knowledge to effectively utilize the FDA pre-submission process, reducing uncertainty and improving the likelihood of a smooth and successful submission. This session is essential for regulatory affairs professionals, quality assurance teams, and medical device developers seeking to navigate the FDA submission process with confidence and efficiency.