FREE ON-DEMAND WEBINAR

Conducting Effective FDA Pre-Sub Meetings: Best Practices to Avoid Timely & Costly Mistakes

For medical device companies, ineffective communication with FDA often leads to time-consuming and costly delays.

Manufacturers may assume their pathway to market is 510(k)…they may assume the testing they did is sufficient…they may assume a clinical trial is not necessary…only to learn later that FDA disagrees. Unfortunately, bad assumptions lead to delays, increased costs or worse…and most of these situations are completely avoidable!

The ‘pre-sub’ program allows manufacturers to request meeting(s) to discuss devices currently under development. Although CDRH issued multiple guidances on the pre-sub program, many companies do not use pre-subs effectively, and some don’t use them at all for fear of increased regulatory burden. And of the 3,843 pre-subs held in 2023, most were not successful! Why? One reason could be because they didn't follow Mike’s mantra: tell, don’t ask…lead, don’t follow!

When used effectively, pre-subs can offer significant advantages to the manufacturer by getting their device to market sooner. But if not used properly, pre-subs can add tremendous burden by increasing time to market.

This webinar will use the case study approach to present the pre-sub process in an interactive fashion, including:

• What is a pre-submission meeting (a.k.a. pre-sub) and when should it be used?
• Why have a pre-sub meeting with FDA, i.e., what are the risks and benefits?
• How early in development should I consider a pre-sub, i.e., concept? design freeze? somewhere in between?
• How does the pre-sub process work and what can the manufacturer expect?
• What info should be provided in the pre-sub package and what should be provided at the meeting?
• Is there a cost to a pre-sub meeting?
• Are there any disadvantages of having a pre-sub?
• What is a successful pre-sub and how do I ensure my pre-sub is successful? 
• What happens after the meeting? How should the manufacturer follow-up? Are the results binding?
• Are there other ways to communicate with FDA beyond pre-subs and when should they be used?

In this presentation, participants will learn best practices to avoid timely and costly mistakes and creative ways to use the pre-sub program to their advantage!