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

Ineffective communication with the FDA often causes costly delays for medical device companies. Manufacturers might mistakenly assume they’ve chosen the right pathway to market, completed sufficient testing, or met the necessary clinical trial requirements, only to find out later that the FDA disagrees.

 These errors lead to delays and increased costs, but they are avoidable. The FDA’s pre-submission (pre-sub) program allows manufacturers to discuss devices under development, ensuring effective communication.

Join us for an informative webinar where you will learn best practices to avoid timely, costly mistakes and creative ways to use the pre-sub program to your advantage!