How to Communicate with the FDA: 10 Insider Tips for Success

I am a former FDA staff member and now back in the private sector. If you are in Regulatory Affairs, you are interacting with FDA or you will at some point. This can be intimidating and nerve wracking.

Here are 10 pointers to make your interactions less painful and more productive:

1. Lead the Meeting with a Clear Agenda

Start every FDA interaction with a detailed and focused agenda. Whether it's a call or a formal Q-sub meeting, you're expected to lead the discussion. Don’t ask the FDA what they want—show them you’re prepared. They will be.

2. Respect FDA Reviewers’ Time and Process

FDA reviewers are busy and oversubscribed. Avoid rambling, and be mindful of their timelines. You may not get a response immediately—be patient and prepared to wait.

3. Ask Targeted, Specific Questions

Generic or open-ended questions rarely get actionable answers. Keep your questions narrow and focused on one topic. Directness leads to clarity.

4. Stay Professional, but Build Rapport

You don’t need to be stiff. FDA reviewers are public servants—not robots. Be polite and clear, but also human. Regular, respectful contact builds trust.

5. Stay Cool—Even When It's Frustrating

You might not like the feedback. Stay calm. FDA sees the industry from a broader perspective. Passion is fine—emotion and insults are not.

6. Disagree? Escalate Professionally

If something feels off, ask to escalate within the FDA’s chain of command. Managers or the ombudsman can help. Always document your interactions.

7. Follow the FDA’s Chain of Command

Do not email or call the FDA Commissioner or Center Director every time you have a problem. Start with your immediate FDA contact and work your way up the chain of command. Make yourself familiar with their organizational structure. The higher you go in the organization; the less familiar people are with your issue. High level people set policy. Your immediate contact and their management are best equipped to help you.

DHF, DMR and DHR. Demystifying FDA medical device development requirements

8. Patience Pays Off—The FDA Moves Slowly by Design

They are playing the long game for all of us. They have structural, legal, and budgetary constraints. You are one of thousands of their customers. They do not necessarily share your urgency.

9. Explain Clearly, Without Talking Down

You know your technology better than FDA, but FDA knows your business sector and its history better than you. They have deep institutional and regulatory knowledge and many subject matter experts. Explain your specific technical issue but be respectful.

10. FDA Isn’t Out to Get You—They’re Just People

FDA has about 20,000 staff members and contractors. Getting three of them to agree is a miracle. A conspiracy would require an unimaginable level of cooperation. FDA is full of normal people like you trying to do a good job. Treat them as such. Keep in mind that, whether its inspections or premarket review, FDA is your collaborator in business success.