FDA Pre-Submission Meetings: Strategies for MedTech Entrepreneurs

When: « Back to Calendar March 2, 2017 @ 8:30 am - 10:00 am
Where: Continuum
21 Drydock Ave #410w
Boston,MA 02210
Categories: MassMEDIC Events

Presented by Michael Drues, Ph.D., President, Vascular Sciences

For medtech companies working to bring their devices to market, ineffective communication with FDA often leads to time-consuming and costly delays. For example, the manufacturer assumes a classification or regulatory pathway for a new device that has not yet been established-only to learn later that FDA disagrees. One way to mitigate such problems is to take advantage of the FDA’s Pre-Submission Program.


The ‘pre-sub’ program-an expansion of the pre-IDE program now collectively referred to as ‘Q-Sub’- allows manufacturers to request meetings regarding development and testing of devices currently under development and/or under regulatory review. Although CDRH issued guidance on the pre-sub program in February 2014, many companies do not use this program effectively, and some don’t use it at all for fear their regulatory burden will be increased rather than reduced.

When used effectively, pre-subs can offer significant advantages to the manufacturer, such as getting their device to market sooner.  But if not managed properly, pre-subs can add tremendous burden to the manufacturer by increasing the time to market.  Knowing when not to use the pre-sub process is just as important as knowing when to use it.

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

  • When should the pre-sub program be used and when should it not be?
  • How does the process work and what can the manufacturer expect?
  • When is it better to meet formally or informally? Should you meet in person or via teleconference? Should meetings take place verbally or in writing?
  • What info should be provided in advance and what should be provided during the meeting?
  • What happens after the meeting? How should the manufacture follow-up? Are the results binding?
  • Are there other ways to communicate with FDA beyond pre-subs and when should they be used?

By Invitation – Free Registration – RSVP Here put Pre-Submission Meetings: Strategies for MedTech Entrpreeurs – March 2 in subject line.