What to Expect from an FDA Pre-Submission Meeting
Bringing a new medical device to market is challenging, but one of the most valuable resources available to sponsors is the FDA’s Pre-Submission (Pre-Sub) program. Pre-Sub meetings provide direct, early feedback from the FDA—helping you validate your regulatory strategy, testing plans, and clinical protocols before committing significant time and resources.
Why Request a Pre-Sub Meeting?
An FDA Pre-Sub meeting is more than a formality—it’s an opportunity to:
Gain clarity on the FDA’s expectations for your device’s regulatory pathway.
Validate testing and clinical strategies before investing in costly studies.
Ask targeted questions about requirements, risk classifications, and data needs.
Build rapport with FDA reviewers early to promote trust and ensure clarity in future submissions.
Think of it as a chance to reduce uncertainty and strengthen your submission before it reaches the formal review stage.
The Pre-Sub Process
At NMCG, we guide clients through every step of the Pre-Sub process:
Strategic Planning: Determining the right timing and scope of your Pre-Sub request based on product stage and regulatory goals.
Drafting the Pre-Submission: Developing a detailed package with device description, intended use, proposed pathway, study synopsis, and FDA-directed questions.
Meeting Preparation: Coaching your team on how to present effectively and frame questions to maximize actionable feedback.
Engaging with FDA: Supporting you during the meeting itself to keep discussions focused and productive.
Post-Meeting Follow-Up: Summarizing feedback, interpreting responses, and integrating insights into your regulatory and clinical plans.
What Happens During the Meeting
Expect FDA reviewers to provide nonbinding feedback on:
Classification and regulatory pathway options (510(k), De Novo, PMA, etc.)
Preclinical testing plan
Clinical testing requirements, if applicable, including study design, endpoints, and statistical considerations
Human factors and usability considerations
While the guidance from the meeting is nonbinding, it’s highly influential in shaping a successful submission.
Why Partner with NMCG?
Pre-Sub meetings can make or break a regulatory strategy. With deep expertise in trial design, protocol writing, and regulatory submissions, NMCG ensures you approach the FDA with a clear, evidence-backed plan. By engaging early and strategically, we help you avoid costly delays, increase submission success rates, and build trust with FDA reviewers.
