Service:
Regulatory Pathway Strategy & FDA Pre-Submission
Client:
Pre-Clinical, Regulatory Strategy Phase
Duration:
3 months
CONFIDENTIALITY NOTE:This case study represents a composite of multiple client engagements with novel medical device technologies. Details have been changed to protect client confidentiality. The regulatory processes described reflect real FDA Pre-Submission interactions.
A Novel Device With No Clear Path
The founder was no stranger to healthcare.
He'd spent 15 years in pharma—big companies, successful drug launches, knew the FDA process inside and out. When he left to start his own company, he thought he understood what he was getting into.
He was half right.
He understood clinical trials. He understood FDA review processes. He understood how to design studies and interpret data.
What he didn't understand: medical device regulation is completely different from drug regulation.
His new company had built software that combined diagnostic capabilities with therapeutic recommendations. It was novel—nothing quite like it had been cleared before.
And that was the problem.
The Question Nobody Could Answer
"Which FDA pathway do we use?"
He'd asked three regulatory consultants. He got three different answers.
Consultant #1: "This is clearly a 510(k). Find a predicate device and show substantial equivalence."
Consultant #2: "There's no predicate for this. You need De Novo classification."
Consultant #3: "Actually, this might be a combination product. You might need both CDRH and CBER involved."
He'd also talked to two CROs. They both said they could run his clinical trial—but they gave him completely different study designs depending on which pathway they assumed he'd use.
Six months into this, he'd spent money on consultants but still had no clear answer.
His investors were getting impatient: "Just pick a path and move forward."
But picking wrong could cost 18-24 months and well over a million dollars.
Why This Matters
Here's what most founders don't understand:
The FDA pathway you choose determines:
What kind of clinical data you need
How much it costs
How long it takes
What happens after you're cleared
If you choose 510(k) but FDA says it's De Novo: You've designed the wrong study. You might need more data, different endpoints, additional safety information. You're starting over.
If you choose De Novo but there's actually a predicate: You've spent 12+ extra months and hundreds of thousands of dollars on a more rigorous path than necessary.
If it's a combination product: You're dealing with two FDA centers, two sets of requirements, and a significantly longer timeline.
He needed clarity before spending money on anything else.
WHAT WE DID
Week 1-2: Deep Regulatory Assessment
I started where everyone else had apparently stopped: actually reading FDA guidance documents.
Not just the general ones. The specific ones for:
Software as a Medical Device (SaMD)
Clinical Decision Support (CDS)
Combination products
De Novo classification
Recent FDA decisions on similar technologies
I also did something critical: I searched FDA's databases for anything remotely similar to what this company was building.
Found 4 devices that had some overlapping characteristics. Pulled their clearance letters, 510(k) summaries, and FDA review memos (where available).
Looked at:
What pathway they used
What FDA asked for
How they classified the device
What clinical data they submitted
Pattern started emerging: Devices with similar diagnostic functions went through 510(k), but devices with therapeutic recommendations had gone through De Novo when they were truly novel.
His device had both.
By end of week 2, I had a hypothesis: This was likely a De Novo device, but there might be a creative 510(k) argument if we framed it a certain way.
But I wasn't certain. And neither would FDA be until they reviewed the actual device.
Time to ask them directly.
Week 3-4: Prepare for FDA Pre-Submission Meeting
FDA offers Pre-Submission meetings specifically for situations like this. You describe your device and ask questions before you design your study or file your application.
Most companies don't use them. They should.
We prepared:
The Device Description: Clear, specific, technical but readable. FDA needed to understand exactly what this device did, how it worked, and who would use it.
The Specific Questions:
"Based on this device description, what is the appropriate regulatory pathway?"
"If this is a 510(k), what would you consider an acceptable predicate?"
"If this is De Novo, what level of clinical evidence would support clearance?"
"Does this meet the definition of a combination product?"
"What are the key risks FDA would want addressed in our submission?"
We didn't ask vague questions like "what do we need to do?" We asked specific, answerable questions that would give us actionable guidance.
The Proposed Study Design (Two Versions): I worked with the founder to outline two possible study designs:
Version A: If it's 510(k) (smaller, comparative study)
Version B: If it's De Novo (larger, more comprehensive study)
We presented both and asked FDA which one would support clearance.
Submitted the Pre-Sub request in week 4.
FDA scheduled the meeting for 8 weeks out.
Month 2: Wait and Prepare
While waiting for the FDA meeting, we weren't idle.
We used the time to:
Prepare for the meeting:
Anticipated FDA's questions about our questions
Prepared backup slides with additional technical detail
Identified who from the company should attend (founder, VP Engineering, me)
Line up CROs based on both scenarios: We talked to CROs about both Study Design A and Study Design B. Got preliminary budgets and timelines for each.
This way, as soon as we had FDA's answer, we could move immediately.
Start drafting the protocol framework: We outlined the key sections of the protocol that would be the same regardless of pathway (inclusion criteria, safety monitoring, data collection methods).
Month 3: FDA Meeting and Outcome
The FDA Pre-Sub meeting happened in week 10.
We presented the device. Walked through the two possible pathways. Asked our questions.
FDA's response was clearer than I expected:
On the pathway: "This would be appropriate for De Novo classification. We don't see an adequate predicate device for the 510(k) pathway given the novel aspects of the diagnostic-therapeutic combination."
On the study design: "Study Design B is appropriate. We'd want to see safety data across diverse patient populations and evidence of clinical benefit, not just diagnostic accuracy."
On specific risks: They identified 3 risks we needed to address that we hadn't fully thought through. (This is why you do Pre-Sub meetings—they catch things you miss.)
On timeline: "If the study is well-designed and the data support the claims, we'd anticipate a De Novo review timeline of 150-180 days after submission."
We asked follow-up questions. They gave clear answers.
Most importantly: We got it all in writing. FDA's official written feedback came 3 weeks later.
Clarity Worth Its Weight in Gold
After 10 weeks, the founder finally had definitive answers:
✅ It's a De Novo device
✅ Here's the study design FDA will accept
✅ Here's what they'll want to see for safety and effectiveness
✅ Here's the timeline to expect
No more consultant opinions. No more guessing. FDA had told us exactly what they wanted.
We Designed the Right Study
Armed with FDA's written feedback, we finalized the protocol.
It was Study Design B (the bigger, more comprehensive version).
Yes, it cost more than Study Design A would have.
But Study Design A wouldn't have gotten them cleared. So the cost was irrelevant.
The CRO contract was signed within 3 weeks of the FDA meeting.
Trial started 2 months later.
What We Saved Them From
If they'd guessed wrong and picked the 510(k) pathway:
They would have designed a smaller comparative study
Spent 12-18 months running it
Submitted to FDA
FDA would have said "this isn't substantially equivalent to any predicate, you need De Novo"
They'd have to do additional studies for De Novo requirements
Total delay: 18-24 months
Total wasted cost: $500K-800K
We saved them from this.
Money saved: $500K-800K (conservative estimate)
Time saved: 18-24 months
The founder told his board: "The Pre-Sub meeting was the best decision we made all year."
Timeline to Market
With clarity from FDA:
Protocol finalized: Month 3
Trial started: Month 5
Trial completed: Month 17
De Novo submitted: Month 18
FDA clearance: Month 24 (6 months after submission, within FDA's projected timeline)
If they'd guessed wrong:
Wrong study completed: Month 18
FDA rejection: Month 20
Restart with right study: Month 22
Right study completed: Month 40
FDA clearance: Month 46+
They got to market 22+ months earlier.
Lessons Learned
1. Novel Devices Need FDA Input Early
If your device is truly novel—meaning there's no clear predicate and you're not sure which pathway applies—don't guess.
Ask FDA. They'll tell you.
Pre-Sub meetings exist for exactly this reason.
2. Consultant Opinions Aren't FDA Decisions
Three consultants gave three different opinions. All three were smart, experienced people.
But only FDA's opinion matters.
Get it in writing.
3. "Just Pick a Path and Move" Is Terrible Advice
The investors wanted him to "just start moving."
If he'd done that, he would have picked wrong and wasted 18 months.
Sometimes the right move is to pause, get clarity, then move fast in the right direction.
Name Withheld (NDA)
Founder & CEO, Medical Device Startup *Client confidentiality maintained
