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Conducting Effective FDA Pre-Submission Meetings: Getting to Market Faster

Mike Drues, PhD (President, Vascular Sciences)

Location: 210D

Date: Thursday, February 7

Time: 8:30am - 10:00am

Track: MD&M West: Regulatory & Quality Update

Vault Recording: TBD

For medical device companies, ineffective communication with FDA often leads to time-consuming and costly delays. Manufacturers may assume a classification or regulatory pathway for a new device – only to learn later that FDA disagrees. The “pre-sub” program allows manufacturers to request meetings regarding devices currently under development and/or regulatory review. Although CDRH issued guidance on the pre-sub program, 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.

Topics covered include:
  • When should the pre-sub process be used and how does it work?
  • What information should be provided in advance and what should be provided at the meeting?
  • What happens after the meeting, and are the results binding?
  • Case examples demonstrating effective use of best practices to avoid timely and costly mistakes