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A Pre-Submission is a request for FDA’s written feedback on a specific question before you file. It sits inside the Q-Submission program, and for a first-time sponsor it is the cheapest regulatory step you will take.
What you get
You send a package that describes the device, the intended use, the pathway you believe applies, and the questions you want answered. FDA aims to provide written feedback within 70 days of receiving the request, or five days before a meeting if you asked for one. The feedback is not binding, but FDA intends to stand by it unless you change the device or new information emerges.
That written record is the point. It tells you which bench tests the agency expects, whether the animal model you have in mind is acceptable, and whether the clinical evidence you plan to collect will support the claim you want to make.
When it pays
A Pre-Submission earns its cost when any of these are true:
- The pathway is not obvious. You are unsure whether the device is Class II or Class III, or whether a predicate exists.
- The technology is new to the review division. Novel materials, a new mechanism of action, or a first-in-kind indication.
- You are planning a first-in-human study. FDA expects an Early Feasibility Study to be preceded by a Pre-Submission.
- The bench test plan is expensive. Fatigue, corrosion, particulate, and durability testing on a cardiovascular implant can run for months. Confirm the plan before you start the clock.
- The clinical protocol involves a judgment call. Endpoints, sample size, and control choice are exactly the things FDA will comment on.
When it does not
If you are filing a 510(k) for a device that is substantively the same as its predicate, tested to the same recognized standards, a Pre-Submission usually adds time without changing the outcome. Spend the effort on the submission itself.
How to ask
Ask a small number of specific questions. “Is our test plan acceptable?” gets a vague answer. “Is the proposed 400 million cycle fatigue test, run at the conditions in section 4, sufficient to support a 10-year implant claim?” gets a usable one. Each question should include your proposed approach and the reasoning behind it, so FDA can agree, disagree, or redirect.
Read the feedback with the same discipline. Where FDA agrees, record it. Where it does not, treat the comment as a requirement, not a suggestion. The submission you file later will be reviewed against that record.
These notes are general information about the US regulatory process. They are not legal advice and do not describe any client's program. All notes