Navigating FDA Interactions: 10 Tips for Regulatory 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. Prepare a detailed agenda 

You must take the lead in your interactions, but be clear and concise. Don’t ask what they want. Whether it’s a short phone call or a formal meeting, be prepared. You can be sure FDA is prepared.

2. Respect their time

Do not ramble on or pester FDA staff. Make sure that you know their timelines and expect to wait the full allotment of time. They have more work than they can handle and every minute is accounted for.

3. Ask specific questions

Do not ask open ended or general questions. Ask questions that focus on a specific topic or problem. Specific questions lead to productive feedback. Don’t assume anything, be direct.

4. Be calm and respectful but not overly formal

FDA is a federal agency full of civil servants. They work for you and the American public. They want to help you, but you must be civil. Excessive formality is not necessary. Develop a rapport with your contacts through regular communication.

5. Do not argue or get emotional 

FDA can frustrate you, but you must remain calm. Try to see their big picture point of view. You have a “me” problem. They have “us” concerns. Do not insult or berate them. You get more flies with honey than with vinegar.

6. If you are not hearing what you want, ask for a meeting with management

Sometimes you may disagree with FDA, and that’s okay. Ask for second opinion by going to management. If you feel there is something wrong with the process, seek out the ombudsman. Make sure you document your interactions with FDA.

7. Use their 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. Be patient FDA can be slow but be patient

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. Take time to explain your thinking and technology, but do not be condescending

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. There is no conspiracy

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.