FDA Regulatory Strategy Advisory | Three River Oaks

One Bad Pathway Decision Can Set You Back a Year

A company that designs its clinical program around PMA requirements when their device qualifies for De Novo loses 12 months and hundreds of thousands of dollars. A team that skips a Pre-Submission meeting walks into a submission blind — and gets a deficiency letter that pushes clearance back another six months.

We've seen both happen. More than once.

FDA regulatory strategy for IVDs isn't something you bolt on at the end of development. The pathway decision shapes every downstream choice — clinical study design, quality system requirements, labeling, timeline, and budget. Get it wrong early and you're rewriting the roadmap under pressure.

Get it right early and everything that follows is cleaner, faster, and cheaper. 

Strategic Guidance from Development Through Approval.

Three River Oaks works with laboratories and diagnostics teams to help clarify regulatory pathways, align technical and clinical activities, and prepare for FDA interactions with confidence — reducing surprises as teams move toward submission and approval.  

IVD Regulatory Strategy Sits at the Intersection of Three Frameworks

21 CFR Part 820. 21 CFR Part 809. CLIA. Most generalist medical device consultants know one, maybe two. Few have worked across all three on real IVD submissions.

Three River Oaks does. Our team has supported FDA 510(k), De Novo, and Pre-Submission pathways specifically for in vitro diagnostic products — molecular assays, immunoassays, point-of-care tests, and companion diagnostics. We know what FDA reviewers look for in IVD submissions, where submissions most commonly fail, and how to position your product before the question even gets asked.

That's not experience you can find at a generalist consulting firm.

Pick Your Starting Point. We'll Tell You If It's the Right One.

A note before you scroll: if you schedule a free consultation, the first thing we'll do is tell you which tier actually fits your situation. No upselling. Just an honest read.

Tier 1 — Regulatory Pathways Sprint

You need to know your FDA pathway before you commit another dollar to development. This is where you start.

In one structured engagement you get: a device classification analysis, an intended use review, a clear pathway recommendation — 510(k), De Novo, PMA, or CLIA-only — and a written FDA Regulatory Strategy Brief your team can build from. Plus a 60-minute session to walk through it together.

Most clients use this to get leadership, investors, and their regulatory team aligned on a single direction. That alignment alone is worth more than the engagement fee.

Tier 2 — Pre-Submission Advisory

You know your pathway. Now you need to get your Pre-Submission meeting right.

Q-Sub meetings with FDA are one of the highest-leverage moments in your regulatory timeline — and most companies walk in underprepared. We help you identify the right predicates, stress-test your substantial equivalence argument, develop the questions that will actually move your program forward, and prepare a briefing document FDA can work with.

Everything in Tier 1, plus predicate analysis, Q-Sub strategy, FDA meeting prep, and a regulatory risk assessment. Up to 3 advisory calls throughout.

Tier 3 — Full Regulatory Engagement

You're moving fast and you want a senior IVD regulatory advisor in your corner for the full pre-submission lifecycle.

90 days. Unlimited advisory calls. Submission readiness review. FDA correspondence strategy. Quality system gap analysis against QMSR. Labeling and Part 809 compliance review. Everything in Tiers 1 and 2, plus the ongoing access and depth that complex regulatory programs actually need.

This tier is for well-funded teams who can't afford to get it wrong and don't want to.

You're probably in the right place if:

You're building an IVD and aren't sure if it's a 510(k), De Novo, or something else entirely. You're preparing for a Pre-Submission meeting and want to make sure you're asking the right questions. You've started down a regulatory path and something doesn't feel right. You need a senior IVD-specific opinion — not a generalist with a checklist.

We work with early-stage diagnostics startups, founder-led teams, and VC-backed companies across molecular, immunoassay, point-of-care, and companion diagnostic platforms.

Advisory only — and that's intentional.

We don't write your submissions. We don't file on your behalf. What we do is make sure that whoever does write and file them — your internal team, a regulatory affairs firm, a specialized writer — is working from the strongest possible strategy.

That's a deliberate choice. Advisory-only keeps our engagements focused, efficient, and honest. We're not billing hours to author documents. We're giving you the strategic clarity that makes every other hour you spend on this more effective.

Not sure which tier fits? That's what the free call is for.

In 20 minutes we can tell you which tier makes sense for where you are, what your biggest regulatory risks are, and what you should be doing right now.

No pressure. No pitch. Just a straight answer. 

connect@threeriveroaks.com | threeriveroaks.com