FAQs
FDA Submission and Regulatory Pathway

Q5: What is a pre-submission meeting with the FDA, and when should we request one?

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A pre-submission (Pre-Sub) meeting (or Q-Submission) is a formal FDA program that allows device manufacturers to submit specific questions about their regulatory strategy before filing a submission. The FDA provides written feedback, typically within 70 calendar days, on questions related to proposed study designs, intended use claims, valid predicate, regulatory pathway selection, and the adequacy of planned evidence packages.

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Pre-Sub meetings are an ideal way to get input on the study design strategy. By soliciting feedback before the design execution and data collection, a manufacturer can avoid lengthy delays and evidence gaps that may result in deficiency letters and require complete response letters after initial submission.  

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The Pre-Sub meeting is particularly important for IVDs with novel biomarker claims, unusual specimen types, or no legal, valid predicates. Landrich Group prepares and manages Pre-Sub meeting requests as one of the highest-value activities in regulatory strategy for U.S. FDA approval.

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FDA pre-sub meetings can be readily scheduled with the FDA.  It is recommended that in the range of 4-6 provocative questions be submitted to obtain FDA feedback regarding the U.S. regulatory pathway, including intended use statement, predicate or comparator devices, and analytical and clinical study designs. The FDA review time for pre-subs is nominally 70 days.  The FDA will typically provide written feedback on pre-sub questions before the 70-day review cycle, and a meeting with the FDA to discuss the feedback is at the discretion of the sponsor or submitter.