A Pre-Submission is a formal written request for FDA feedback on a planned submission, filed under the FDA's voluntary Q-Submission program. For an EFS, it de-risks the IDE: describe the device, the clinical context, and the EFS rationale, then ask specific questions about testing sufficiency, risk mitigation, and study design. File before the IDE, once the concept is describable and the plan still changeable. The FDA responds in writing — or with written feedback followed by a meeting. The EFS guidance path starts here.
Figures attributed; general information, not regulatory advice.
A Pre-Sub is a formal written request for FDA feedback on a planned submission — here, an EFS IDE — inside the FDA's Q-Submission program, the agency's voluntary framework for early interaction before anything formal is filed. The FDA's first recommended step for an EFS is a conversation, followed by a Pre-Sub describing the device, clinical context, and EFS rationale (sources: FDA EFS program and FDA EFS guidance). Nothing compels a sponsor to file one — but skipping it means negotiating testing expectations and risk mitigation inside the IDE review clock.
It de-risks the IDE: every question answered in the Pre-Sub cannot become an IDE deficiency. It settles the hardest negotiation — how much nonclinical evidence is enough before first clinical use — with time to run more testing if needed. And it protects the FDA's 30-day first-cycle IDE target, which is reachable only when the Pre-Sub leaves no surprises.
Before the IDE — never after. File when the device concept and clinical context are describable enough to ask specific questions, but early enough that the answers can still change the plan. Not so early it is vague, not so late it is theater.
Five elements: device description (the design may not be final — the EFS program permits that); clinical context and unmet need; development plan showing where the EFS fits; why EFS is the right vehicle; and the heart of the document — the specific, numbered questions you want FDA to answer about your proposed approach.
Two modes under the Q-Sub program. Written feedback suits narrow, mostly settled questions and produces a clean record. A meeting — with written feedback shared in advance — suits strategic questions about testing sufficiency, risk mitigation, or study design. The operative timeframes are defined by the Q-Submission program; consult the current FDA guidance for the exact clock.
Ask about your specific testing plan: are our nonclinical testing plans sufficient? Ask about mitigation: are the clinical risk-mitigation measures adequate — site selection, investigator experience, monitoring, stopping rules, follow-up? And ask about change: is our design-change plan acceptable, since the EFS program contemplates device modifications informed by early clinical experience?
Vague questions ("is our plan acceptable?") invite non-answers. Asking the FDA to design the study — the agency gives feedback on your proposal; a Pre-Sub without one is wasted. And skipping the Pre-Sub entirely: filing the IDE cold and discovering the testing-expectation gap inside the review clock.
Draft the Pre-Sub around your questions; submit and receive FDA feedback in writing (or writing plus a meeting); close the loop on open items — do the extra testing or mitigation work now; then write the IDE from the agreed plan, targeting the 30-day first-cycle goal with no structural surprises.
A formal written request for FDA feedback on a planned submission, filed under the voluntary Q-Submission program. For an EFS: device, clinical context, EFS rationale, and specific questions — before the IDE is written.
Before the IDE, once the concept is describable enough to ask specific questions and the plan is still changeable. Not after the IDE is written.
Device description, clinical context and unmet need, development plan, EFS rationale, and specific numbered questions — the heart of the document.
Written feedback for narrow, settled questions; a meeting (with written feedback in advance) for strategic questions on testing, mitigation, or design. The record — written responses plus meeting minutes — is what the IDE is built on.
The Q-Submission program defines the operative timeframes — consult the current FDA guidance for the exact clock. The FDA always responds in writing, and meeting requests include written feedback in advance.
Nothing requires it, but skipping it is the most common expensive mistake: the testing-expectation negotiation then happens inside the IDE review clock, where every week of rework costs runway.
Related: FDA EFS program · EFS IDE · US EFS support · US vs Latin America