How you engage with FDA reviewers during 510(k), De Novo, or PMA reviews can shape your outcome. Learn best practices for interactive reviews, responding to deficiency letters, and building productive relationships that keep your submission moving forward.
Communication with FDA reviewers extends beyond formal meetings – it happens throughout the submission review process. How you interact with the FDA during a 510(k), De Novo, or PMA review can significantly impact the efficiency and outcome of that review. In this section, we share best practices for professional, productive communication with FDA reviewers. From responding to inquiries and deficiency letters to leveraging FDA’s Interactive Review process, these tips will help you avoid common missteps and foster a cooperative relationship with your review team.
When you submit your application, it goes through a structured review with defined timelines. Early on, the FDA conducts an acceptance screening (to ensure your submission is complete). Once accepted, the substantive review phase begins. During this phase, by Day 60 FDA aims to have a Substantive Interaction with you – either:
Knowing this framework helps shape your communication. Ideally, you want to stay in interactive communication and avoid formal hold letters when possible. FDA’s guidance on communication (for 510(k) and other submissions) emphasizes that the Interactive Review process is meant to improve timeliness by resolving issues informally when feasible. In an interactive review, the lead FDA reviewer will reach out via email or phone to ask clarifications or request additional data. This is a window of opportunity for you to address questions quickly and keep the review moving.
If you do receive a formal AI request letter, don’t panic – but recognize it as a more serious set of deficiencies. You will have 180 days to respond to an AI letter. Take that timeline seriously: failing to answer all deficiencies adequately within 180 days will lead to your submission being withdrawn (you’d then have to start over with a new submission). This policy is strictly enforced, so timeliness and completeness in your responses are crucial.
Believe it or not, FDA reviewers are people too – scientists, engineers, physicians – with a job to do. Approaching communications with a collaborative mindset can set a positive tone. Always be honest and forthcoming. If an issue exists (e.g., a test failed), don’t try to obscure it; instead, acknowledge it and explain how you will address it. Reviewers value integrity. As one industry expert noted, “FDA reviewers…really do want to help you and your product move forward. Common courtesies such as being on time, being well prepared and organized can go a long way.” In practice, this means sending well-prepared materials and showing respect for the reviewer’s time by not making them dig for answers.
If you disagree with a reviewer’s request (for instance, they ask for a costly new test you feel is unnecessary), approach it diplomatically. Provide a rationale and perhaps alternative solution in a Q-Submission if it’s a major issue. There are formal ways to handle disputes (e.g., request supervisory review or use the CDRH Ombudsman), but often a reasoned discussion can resolve it. Sometimes bringing in a seasoned regulatory consultant to communicate on particularly contentious points can ensure the message is framed appropriately – the goal is to persuade with science and logic, not emotion.
Despite best efforts, misunderstandings can happen. If you feel communication has broken down or you are not receiving timely feedback, you have options. One is to politely escalate by involving the branch chief or division management – FDA generally does not mind if done professionally. Another is the formal “request for supervisory review” (sometimes called an appeal or 21 CFR 10.75 appeal) if you believe an issue was handled incorrectly. There’s also an official Device Dispute Resolution Panel for scientific disputes, though this is rarely needed if communications are managed well earlier.
Often, bringing in an outside perspective (such as a consultant or someone who previously worked at FDA) can help interpret reviewer comments and improve the communication. They may suggest a different way to present information that resonates better with FDA expectations.
Mastering communication with FDA reviewers is an essential skill for a successful submission. By responding promptly, clearly, and cooperatively to FDA inquiries, you not only avoid delays but also build a positive working relationship with the Agency. Smooth communication can turn what could be a tense, adversarial process into a more straightforward collaboration aimed at getting a safe, effective device to market. Our firm often acts as a liaison in these communications, leveraging our experience to ensure that nothing is lost in translation between sponsors and FDA. With the right approach, even challenging questions can be addressed effectively, keeping your device approval on course.
