The Regulatory Roadmap Isn’t a Detour—It Is the Route

Why early FDA strategy is business strategy—and how to navigate it without losing your mind (or your momentum)

When people talk about startup roadmaps, they usually think of product milestones, funding rounds, or go-to-market timelines. But in regulated industries—especially in medtech, diagnostics, and fertility health—your regulatory roadmap isn’t a detour or a box to check along the way.

It is the route.

If you're building a product that needs FDA clearance or approval, your regulatory strategy should be woven into your product strategy from the start. Wait too long, and you risk delays, dead-ends, or worse—designing a product that can’t be cleared as intended.

FDA Pathways in Plain English: 510(k), De Novo, and PMA

If you’ve ever Googled “FDA device pathways” and immediately regretted it, you’re not alone. Let’s break it down in human terms:

510(k) – “Like something already on the market”

This is the most common pathway. You’re showing that your product is “substantially equivalent” to an already-approved device. It’s faster and cheaper than other routes—but you must have a valid predicate device to compare to.

Best for: Iterative improvements or new versions of existing tech.

De Novo – “New, but low to moderate risk”

If there’s no existing device quite like yours, but it’s not high-risk, this is your path. You’re asking FDA to create a new device classification. It takes longer than 510(k), but it opens the door for future 510(k)s for others (or yourself).

Best for: First-of-its-kind devices with moderate risk.

PMA (Premarket Approval) – “High risk, high bar”

This is the most rigorous pathway—requiring clinical data and detailed evidence. It’s for Class III devices that are life-supporting, life-sustaining, or high risk. It’s time- and resource-intensive, but sometimes necessary.

Best for: Breakthrough or critical-care tech.

Why You Can’t Skip Early Regulatory Planning

If you're building something innovative, the earlier you start talking to the FDA, the better.

Pre-submission (pre-sub) meetings are one of the most valuable tools in your toolkit. They let you present your product and ask questions before you formally apply. It’s like getting the syllabus before the exam—and yes, it can save you months.

Early engagement lets you:

• Align product design with regulatory expectations

• Get clarity on which pathway applies to you

• Identify what clinical or bench data you’ll need

• Build credibility and trust with reviewers

  
  

In our own work developing a novel fertility treatment, we’ve seen firsthand how early, thoughtful regulatory engagement helped shape not just our filing strategy—but our formulation decisions, labeling strategy, and market timeline.

Things We Wish We Knew Sooner

Every founder or product team in this space has a “we learned this the hard way” story.

Here are a few of ours:

• Regulatory is not a one-off task—it’s a thread throughout product development.

• You don’t need to have all the answers before a pre-sub. You do need to frame smart questions.

• Hire or consult with a regulatory expert early. It’s more cost-effective than fixing a broken filing.

• Understand how FDA classifies risk. Your sense of risk and theirs may differ.

• Read real FDA decision summaries. They’re public, and they’re gold.

Helpful Resources to Start With

Want to dig in further? Here are some essential FDA resources we found useful:

• FDA 510(k) Overview

• FDA De Novo Pathway Guide

• FDA PMA Overview

• Pre-Submission Guidance (aka the Q-Sub Program guide)

• Device Classification Panels

Bottom line: Regulatory strategy isn’t just about compliance—it’s a competitive advantage. When you treat the FDA as a partner, not an obstacle, you can build faster, smarter, and more confidently.

Let’s stop treating regulatory as a roadblock and start seeing it as what it really is: the map that helps you get where you’re going.