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! 

Watch the webinar

Conducting Effective FDA Pre-Sub Meetings- Best Practices to Avoid Timely & Costly Mistakes
Who should attend?
  • Medical Device Executives
  • Product Development Engineers and Management
  • Quality Professionals and Management
  • Regulatory Affairs Professionals and Management
  • Clinical Affairs Professionals and Management
Register Now  

Hosted by

Laura Maher

Medical Device Guru II,
Greenlight Guru

M.Drues Headshot circle (1)
Michael Drues

Vascular Sciences

Greenlight Guru logo

About Greenlight Guru

Greenlight Guru is the leading cloud-based platform purpose-built for MedTech companies. The end-to-end solution goes beyond traditional QMS needs by integrating cross-functional teams, processes, and data throughout the entire product lifecycle so device makers can proactively overcome execution gaps, streamline compliance, and accelerate market success.

Greenlight Guru’s platform is used by organizations across the globe that are replacing their disjointed, legacy tools and solutions to bring life-changing products to people faster, and with less risk.

Visit our homepage to learn more.


About Vascular Sciences

Vascular Sciences has been conducting seminars specifically geared toward medical device design, development and testing since 1996.

These seminars have been requested by companies ranging in size from start-up to fortune 100 companies, the European Patent Office and the FDA Centers for Devices and Radiological Health (CDRH).

Visit their website to learn more.

Featured In