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. Unfortunately, most of these delays are completely avoidable!
The ‘pre-sub’ program – an expansion of the pre-IDE program– allows manufacturers to request meetings regarding devices currently under development and/or regulatory review. Although CDRH issued guidance on the pre-sub program in 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 by getting their device to market sooner. But if not used properly, pre-subs can add tremendous burden by increasing time to market. This presentation 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?
• What info should be provided in advance and what should be provided at the meeting?
• 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! For additional information, check out:
• Column: How To Make The Most Of Your Pre-Sub Interactions with FDA (Med Dev Online, Feb, 2015) here.
• Column: Communicating With FDA: How (And When) To Get It Right (Med Dev Online, June, 2015) here.
• Editorial: 3 Tips To Vastly Improve Your FDA Communication Strategy (MDDI, May, 2014) here.
• Podcast: How To Make The Most Of Your Pre-Submission Interactions With FDA here.
• Podcast: How to Properly Use the FDA Pre-Submission Process and Why It’s So Important here.
• Podcast: When And How To Interact With The FDA (MED Device Online, March, 2015) here.
• Workshop: FDA Pre-Submission Meetings: Strategies for MedTech Entrepreneurs (MassMEDIC, March, 2017) description here / podcast and handout here.
• Webinar: Communication With FDA: What Do We Say and How Do We Say It? (GWU, Jan, 2016) here.
• Guerrilla Regulatory Strategy (MED Dev Online), GreenLight.guru podcast series and Mike on Medtech (MPO Magazine)
Michael Drues
