A regulatory strategy and an FDA Pre-Sub in four weeks.

That is what the engagement exists to answer, and we will not guess on a sales call. What we will tell you on the first call is which way it leans and why.

Two things worth knowing. Roughly half of De Novos are not granted, and FDA has signalled a preference against them, so a defensible 510(k) argument is worth real effort. And predicates stretch further than most people assume: FDA permits a hybrid argument across multiple predicates when one device combines separately cleared functions. That has turned a number of apparent De Novos into 510(k)s.

Four weeks from kickoff to a filed Pre-Sub. Then about ten weeks, almost all of it waiting on FDA, to the meeting itself.

It depends on our team’s availability, but we can typically start a new engagement within two to four weeks. To preserve your spot in our schedule, we require the first invoice to be paid up front.

We use the term clinical study to mean a study on real clinical data. Most AI-enabled devices do need one, although for many of them a retrospective study is sufficient, which is dramatically faster and cheaper than a prospective trial.

CADe and CADx devices typically also need an MRMC reader study on top of standalone performance. Which category you land in follows from your claims, which is exactly why claims get tightened in week one.

Often, yes. We look hard at what you have before assuming you need more.

The constraints that usually bite are US-representative demographics, site diversity, and whether your reference standard will survive scrutiny. Single-site data annotated by a single reader is the most common fatal problem we see.

We ask FDA about data reuse in the Pre-Sub so the answer is on the record before you spend.

In scope: everything in the strategy document and the Pre-Sub package. Product code, pathway and predicate analysis, indications and claims, the clinical validation design, the power study, the regulatory risk register, the eSTAR filing, FDA meeting preparation, running the meeting, and the minutes.

Not in scope: running the clinical study, FDA user fees, and data acquisition. We design the study and coordinate with CRO partners, clinician recruiters, and data brokers, but we are not a CRO. Study execution is usually the largest cost in the program, so we size it for you early.

Sometimes, and less often than people hope. FDA now expects some real-world evidence depending on the claims, the program is under scrutiny because of designations that never produced a cleared device, and the data suggests BDD can actually slow a clearance by inviting more review.

It remains valuable for one thing: fundraising. It costs nothing to apply, you do not need a finished device, and a granted designation is a strong investor signal. We are selective about which applications we take on, and if yours is not winnable we will say so rather than bill you for the attempt.

We do not sell BDD standalone. The application is built out of the strategy work, so the strategy comes first. Our Breakthrough Device and STeP Programs FAQ covers the criteria and what the designation does and does not buy you.

We do. Expect about five hours a week from your side: one or two hour-long meetings plus roughly three hours of homework, concentrated in the first week when we lock the intended use. You provide access and decisions; we write the document and the submission.

One thing to plan for: we typically need a clinical subject matter expert in a few of those meetings to help design an optimal study. The reference standard, the reader task, and the acceptance criteria all get better when a clinician who treats these patients is in the room. If you do not have one, we can bring one in.

Sometimes that is an easy question to answer. Sometimes it is not.

The typical focus of a regulatory strategy engagement is developing the clinical evidence strategy and getting FDA’s buy-in on the clinical study protocol. For some products, though, the central regulatory question is whether it is a device in the first place.

We can assess that for your product, and help you define how much functionality you can add while staying on the non-regulated side of the line.

Around 60 FDA submissions over nine years of regulatory work, on top of about fifteen years building SaMD. Two did not clear on the first attempt, and both cleared on resubmission. Roughly 70% of our work is medical imaging and nearly all of it involves AI/ML.

Yes. We have submitted a number of Predetermined Change Control Plans, and we assess whether one is appropriate for your device as part of the strategy.

Unfortunately, no. We preserve the limited capacity of our expert team for companies that are funded well enough for us to deliver maximum value in bringing them to market.

Two things, in writing, for devices that qualify. The Pre-Sub is submitted within four weeks or you receive a partial refund. And if you then partner with us on the marketing application and FDA does not grant clearance, you receive a refund on this engagement.

The clock stops if we are blocked: if we cannot get time with your team, if a key decision such as the intended use stays open, or if an invoice goes unpaid for fourteen days. We will tell you when that happens rather than discover it at the end.

Sometimes you can. A Pre-Sub is a tool for controlling regulatory risk, so the answer depends on what your risks are, how likely they are, and what they cost if they land.

Working with us removes some of that uncertainty before FDA ever sees it. We interact with FDA on AI-enabled devices often enough to answer directly much of what another consultant would have to ask. That is worth saying plainly, because consultants have an obvious incentive to recommend a Pre-Sub.

A Pre-Sub earns its place when the functionality is novel and the study behind it is expensive. If guessing wrong on the study design means running it twice, two to three months is cheap. If FDA’s answer cannot change what you would do anyway, skip it.

Our Pre-Sub FAQ works through this in more detail, including when a strong predicate is reason enough to skip it.

Not in the base engagement, but we offer a reimbursement add-on that runs alongside it. It is worth considering early, because your indications for use determine how you can bill. Write the claims for FDA without looking at the coding consequences and you can end up with a cleared device that has no clean billing path, or one quietly bundled into a facility fee you do not capture. That decision gets made in week one whether or not anyone is thinking about reimbursement.

What it is: two weeks, run in parallel with the regulatory work. Candidate CPT, HCPCS and DRG codes with current Medicare rates; a mapping of whether your output bills standalone, as a procedure add-on, or bundled into an existing fee; benchmarks from cleared AI/ML devices in your clinical domain with their codes and published rates; and a flag sheet marking where the draft intended use helps or hurts you commercially. Two joint calls with you, the coding consultant, and the regulatory team, then a written summary.

What it is not: a full reimbursement strategy. It ends with a scope for that work, which covers society engagement, code applications, payer outreach, and the NTAP and TPT pathways, and is a separate and much larger engagement. We do not do coding in-house. We bring in a reimbursement consultant and integrate their findings with the regulatory strategy, so you get one answer rather than two reports that disagree.

When you need CE Mark or other non-US submissions as the primary goal. We are a US FDA firm and partner with European consultants rather than pretending otherwise.

When the device is hardware-first and the software is incidental. We do not take on implantables, catheters, surgical instruments, orthopedic hardware, or the electrical and mechanical engineering on capital equipment. We work on combination products where the software is the substance of the device, and we partner for the hardware side rather than pretending we cover it.

When you want a light review or hourly consulting. We add the most value when we are playing a major role in your strategy, so if you are after a second set of eyes, we are not the right fit.