FDA Device Meetings
FDA Device Meetings
Any meeting with the FDA on it’s White Oak campus can be intimidating, but a FDA device meeting to assess both pre-market approval and enforcement action adds particular pressure. That is exactly the meeting I’ve been engaged in over the past two days. This post contains a few reflections on FDA device meetings that will be applicable whether meeting at the FDA’s headquarters in Silver Spring Maryland (just outside of Washington D.C.) or at a District Office.
There are number of variables to balance in a FDA in-person meeting: process, terms, regulations and statutes, and personalities. Any FDA device meeting will begin with the administrative steps of coordinating a meeting.
If you are visiting the FDA’s headquarters in Silver Spring Maryland (just outside of Washington D.C.) there are a number of administrative steps to tend to. Before you arrive to the FDA campus an FDA employee will coordinate the time and building location. The FDA campus is extensive and verifying the building number will be important for your arrival. Take a FDA campus map and plan your route – a taxi driver may only know the main entrance. If you are visiting the FDA campus from anywhere outside the US be sure to plan far in advance the appropriate visitor form. Upon arriving to the FDA campus you will need to check-in with security, take a photo for your visitor pass, and wait for an escort to guide you to your meeting.
Coordinate Your Team
Before any FDA meeting I meet my clients at an off-site location for lunch. It is helpful to review talking points and air concerns. An off-site meeting also ensure everyone departs together with appropriate instructions. The FDA generally only allows one or two hours for a meeting. It can be broken out over one or two days. Use this time wisely, which means planning in advance.
Once on the FDA campus it is important to act professionally. Even in enforcement circumstances where the stakes are high restrain frustrations. The FDA agents at the meeting will range from device experts in the appropriate review panel, to policy and compliance agents. When viewed as an opportunity to engage and find a cooperative partner the meeting can be incredibly fruitful.
Are you in trouble with the FDA?
Don’t panic — you’ve got backup. Download 5 Tips to Help You Navigate FDA Enforcement and learn how to resolve the situation right now.