“His palms are sweaty, knees weak, arms are heavy…” Was Eminem talking about his first encounter with the Center for Devices & Radiological Health (CDRH) at FDA? Why does the anticipation of a “first date” with CDRH send your heart into overdrive? And what do you need to do to prepare adequately so you don’t feel like a hormonal teenager about to go on a first date?
Sonna Patel-Raman, PhD | Consultant II |
Halloran |
Here’s what you can you do to ensure success on your “first date” with CDRH—from asking them out to that awkward goodbye.
1. First of all, ask yourself – do I really want to date CDRH?
Yes! It’s free and easy. And you can get input into any aspect of your product life cycle, but to make a good impression on that date, you really need to be prepared so you are well regarded from then first interactions.
2. How should you ask them out?
Follow the CDRH pre-submission guidance. If you do, you are pretty much guaranteed that they will say yes. Meet the requirements outlined in the pre-submission guidance for a high quality submission (i.e., ensure that it’s organized, clear and concise, and you’ve identified your questions) and ask for a face-to-face meeting, a teleconference, or just a written response.
3. What are you going to talk about?
Identify your critical issues—these can vary depending on where you are in your product development cycle. Get early input from all of the appropriate stakeholders and plan to meet regularly with your team. Questions can range from those about device classification and the regulatory pathway to more specific questions about pre-clinical bench testing and animal studies. If you are further along, you may be ready to discuss the design of your pilot or pivotal study. Your questions should focus on specific issues that result in an answer that provides value. Questions such as “How should we design our clinical study?” or “What CRO do you recommend?” can be seen as unprepared and unseasoned vs. “Do the clinical trial endpoints meet with the Agency’s expectations?” which will be seen as pointed and experienced. Don’t be seen as an awkward dater, knocking the potential out of the relationship before even getting to first base!
Questions should be specific, targeted, and not open ended in either time or intent. Open-ended questions are difficult for CDRH to give you concrete feedback.
4. Make like Nike and Just Do It! Ask them out.
Once you have organized your pre-submission with the right questions (according to the guidance document), send it in! If this is your first time making a submission, get an expert to look it over so it will be met with an understanding that you know what you are doing. Everyone likes to place their best foot forward and feel confident, and have intentions clearly articulated before heading out into the dark.
5. Pre-date ritual
Put your heels on. While you wait for your date, you should be getting ready with your stakeholders. Practice internally and identify questions that CDRH may ask with an articulate and plausible answer that provides the agency with the assurance that you have been around the bases before, even if it’s your first time. Consider obtaining an external perspective for complex issues—someone who can help you understand CDRH’s current thinking. Also consider bringing along experts (design engineers, clinicians, statisticians) who can answer questions from the CDRH experts at the meeting, kind of like a suave but highly respectable big brother who will watch out that you stay in the “safe zone”.
PRO TIP: CDRH likes to talk to the engineers and understand how your device works.
6. THE BIG DATE
Relax. You’re as prepared as you’ll ever be. Plan to achieve agreement on critical issues, obtain clear feedback, and determine next steps. For some of you, that may mean a follow-up pre-submission meeting, which doesn’t have to be face-to-face. As for the fake yawn/arm around the shoulders move? Don’ÃÂt necessarily try to make any big commitments right now, and for sure, you shouldn’t expect any either. Can’Ât hurt to be friendly, but don’t go too far and expect instant agreement with all of your questions. And never be confrontational.
7. After the awkward goodbye at the door…
You’ve met with CDRH and discovered it wasn’t so bad! If you think you have more questions about another issue, be sure to mention to CDRH that you might be interested in a follow-up meeting to discuss. Draft meeting minutes and summarize key points. Provide the documentation for CDRH to review. Determine if you need a follow-up meeting—i.e., a second date!
Stay tuned…
(By the way—this isn’t how I’d recommend
ACTUAL dating…)
