These are in direct conflict.

What Happens with “Best-in-Class” Novel Features

If your device has several novel features that meaningfully change how it works or what it does, you’re likely looking at:

Option 1: Not 510(k) Eligible

FDA may determine it raises new questions of safety and effectiveness that can’t be answered by comparison to existing devices.

Your options for getting through regulatory clearance go from 510(k) to:

• De Novo pathway (if low-moderate risk, first of its kind)
• PMA pathway (if high risk or significant novelty)

Both require clinical data. Both take 1-3+ years minimum. Both cost significantly more.

Option 2: 510(k) with Special Controls

Sometimes you can get a 510(k) if your novel features can be adequately evaluated through:

• Performance testing (not clinical studies)
• Bench testing that demonstrates safety
• Labeling that appropriately describes the technology

But this only works if the core function and intended use are substantially equivalent.

The Strategic Question

Before you finalize your device design, you need to decide:

Path A: Optimize for 510(k) eligibility

• Design with clear predicate in mind
• Novel features are incremental improvements, not fundamental changes
• Materials, technology, intended use stay substantially equivalent
• Market as “30x better performance” but demonstrate substantial equivalence

Path B: Design truly novel device, accept longer pathway

• Pursue breakthrough innovation
• Plan for De Novo or PMA pathway
• Budget 2-3 years and clinical studies
• Potentially stronger IP and market differentiation

Examples

510(k) Success with Performance Claims:

KnoxFog – anti-fog that lasts 30x longer

• Novel performance (way better than competitors)
• But core function (anti-fog) and mechanism stayed substantially equivalent to predicates
• Performance difference demonstrated through testing, not clinical trials
• Result: 510(k) eligible

510(k) Failure – Forced to De Novo:

Surgical robot with novel kinematics and approach

• Core technology fundamentally different
• Predicate robots didn’t have comparable features
• FDA said “raises new questions”
• Result: De Novo pathway required, 3+ years

The Mistake Founders Unknowingly Make

They design the best possible device first, then ask about regulatory pathway. When is comes to innovation, this is how it’s done. BUT because most startups are underfunded, they can’t always afford to take the long path of DeNovo or PMA.

By the time they realize their “best-in-class” design isn’t 510(k) eligible, they’ve:

• Spent 1-2 years in development
• Raised capital based on 510(k) timeline assumptions
• Made commitments to investors/partners
• Now face choice: redesign (lose time) or pursue longer pathway (lose timeline)

Both options are expensive.

The Right Approach

Regulatory thinking should inform design from day one.

Early Stage (Concept):

“We want to solve X problem. What regulatory pathways exist for devices that do this? What are the predicates? What features would push us out of 510(k)?”

Design Phase:

“This novel feature is amazing, but does it fundamentally change our substantial equivalence argument? Can we demonstrate safety/effectiveness through testing, or would we need clinical data?”

Before Design Lock:

“Let’s validate our regulatory pathway assumption before we commit to manufacturing.”

Your Specific Design Question

If your device has several novel features, you need to ask:

1. What’s novel about them?
   • Performance improvement? (Usually okay for 510(k))
   • Different materials? (May require additional testing but often 510(k))
   • Different mechanism of action? (Red flag for 510(k))
   • Different intended use? (Probably not 510(k))
2. Can you demonstrate substantial equivalence despite the novelty?
   • Are you comparing to the right predicate?
   • Can testing data show safety/effectiveness without clinical studies?
   • Do the novel features raise new questions FDA can’t answer by comparison?
3. What’s your risk tolerance?
   • If you’re not confident it’s 510(k) eligible, do you have runway for De Novo?
   • Can you modify design to preserve 510(k) eligibility without losing core value?
   • Is the novelty worth the regulatory risk?

Questions to Help You Assess:

1. What are the novel features specifically?
2. What predicate device are you comparing to?
3. Does your predicate have comparable features, or are yours fundamentally different?
4. What does your device do that the predicate doesn’t do?
5. Have you had any preliminary discussions with FDA or regulatory experts about pathway?

Bottom Line

“Best-in-class with several novel features” absolutely risks not being 510(k) eligible.

The key is understanding which novel features create regulatory risk and whether you can demonstrate substantial equivalence despite them.

This is exactly the kind of strategic assessment you should do before you’re too far down the development path.

Want to talk through your specific situation? I can help you evaluate whether your novel features push you out of 510(k) or if there’s a path to maintain eligibility while preserving your competitive advantages.

This is one of the most critical early decisions device companies make – and getting it wrong is expensive.

Background

“I’m a former professional dancer turned medical device CEO. When we started developing an anti-fog solution for surgical endoscopes, I knew FDA clearance would be complex and expensive.

I wanted to hire regulatory experts from day one. But my science team pushed back hard – they insisted consultants would just rip us off and that they could handle the submission themselves. ‘We know the science. How hard can regulatory paperwork be?’

Their confidence came from strong academic research backgrounds. But academic research and FDA regulatory strategy? Completely different games.

Spoiler: I should have trusted my instincts.”

Act 1: The Mistakes Pile Up

“Here’s where my well-intentioned but inexperienced team got it catastrophically wrong:

Issue #1: Biocompatibility Testing – ‘We Don’t Need It’

My team insisted biocompatibility testing wasn’t necessary for our device. They were brilliant chemists who understood the materials intimately. ‘These are safe,’ they said. ‘FDA will see that.’

Wrong.

FDA doesn’t care how confident you are about your materials. They want ISO 10993 data. Period. No discussion.

By the time we realized we actually needed full biocompatibility testing, we’d already wasted months on a submission built on a faulty foundation.

Issue #2: Sterility – The Six-Figure Assumption

Here’s where things got really expensive.

My science team insisted our gel was ‘aseptically sterilized’ due to its ingredients. They also told us it couldn’t be gamma radiated – claimed it would destroy the product – without ever actually testing it.

Based on their confidence, we submitted our first 510(k) claiming aseptic sterilization, backed by simple in-house testing data.

FDA came back: ‘Where’s your aseptic process validation?’

That’s when I learned what aseptic process validation actually means: you have to validate every single step of your manufacturing process to prove sterility. Environmental monitoring. Equipment qualification. Personnel qualification. Media fills. We’re talking potentially six figures in validation studies.

We didn’t have that. We’d never budgeted for it. My science team had no idea this was even required.

The Mid-Submission Scramble:

In the middle of our active 510(k) review, I made the call:

‘Let’s actually test gamma radiation before we assume it destroys the product.’

We tested it. Product was completely fine. The assumption was wrong.

We switched to gamma sterilization, ran validation testing, and revised our entire sterility approach mid-submission – while FDA was actively reviewing us.

Cost of that baseless assumption? Months of delays, emergency testing, submission revisions, and the stress of changing fundamental product specs during FDA review.

Issue #3: Cytotoxicity Failure – The Breaking Point

When our cytotoxicity testing came back as failures, my science team completely froze. They’d run in house tests with good results. The third-party testing returned puzzling results. Everything passed with flying colors EXCEPT cytotoxicity results. Our science team had no idea what to do next other than suggesting a long list of testing that could, in all probability, lead us down the preverbal rabbit hole with no explanation for the failure.

That’s when I realized I had to take control.

I found a cytotoxicity expert myself, worked directly with them to understand what was actually happening at the cellular level, and figured out how to resolve the failure.

This wasn’t a materials problem – the gel was fine. It was a testing protocol and interpretation problem. My brilliant science team (and they really are brilliant) simply didn’t know how to troubleshoot FDA-specific testing failures.

The Decision to Withdraw:

After months of these cascading missteps, I made the hardest call of my career: withdraw the submission.

My team fought me. ‘We’re so close!’ they said. ‘We can fix this!’

But we weren’t close. We were building on a foundation of regulatory mistakes, each one compounding the last. Better to restart properly than to keep patching a fundamentally flawed submission.”

Act 2: Doing It Right

“Round two, I ran things very differently:

I brought in regulatory expertise – not to replace my science team, but to bridge the gap between scientific excellence and regulatory requirements.

We properly scoped biocompatibility testing from day one. No more ‘we don’t need that.’ We followed ISO 10993 decision trees systematically, understanding what FDA required before we spent a dollar on testing.

We used gamma sterilization with proper validation – tested it first, confirmed it worked, then built our regulatory strategy around what we’d actually proven, not what we assumed.

We used our previous FDA submission proactively as a Q-Submission, answering specific questions about our approach before committing to expensive testing protocols.

We worked with the right testing labs – ones with FDA expertise, not just technical capability.

Result? Clearance in just over three months on our second submission.

The Real Cost:

The consultant fees we resisted? They would have saved us at least a year and probably $150K+ in wasted testing, wrong protocols, and submission revisions.

More importantly, they would have saved us from the soul-crushing experience of watching smart people make expensive mistakes because they didn’t know what they didn’t know.

Act 3: Why This Became Evolve Regulatory Strategies

“This experience completely changed how I think about regulatory strategy.

Here’s what I learned:

Scientists think: ‘Is this safe and effective?’
FDA thinks: ‘Did you provide the exact evidence we require in the exact format we accept?’

Those are not the same question.

• Your PhD scientists probably don’t know ISO 10993 decision trees.
• Your CSO probably doesn’t know what aseptic process validation entails.
• Your engineers probably don’t know FDA-accepted testing protocols.
• And when testing fails, they probably don’t have the regulatory expert to call.

None of this makes them bad at their jobs. They’re brilliant at the science. They just shouldn’t be making regulatory strategy decisions.

I started Evolve Regulatory Strategies because I lived this nightmare.

I know what it’s like to trust brilliant technical people who are confidently wrong about regulatory requirements.

I know what it costs to learn FDA requirements through expensive trial and error.

I know what it’s like to become a regulatory problem-solver by necessity – finding cytotoxicity experts at 10pm, making calls to pivot sterility strategies mid-submission, teaching yourself ISO standards because no one else on your team knows them.

And I know what it’s like to do it right the second time – with the right expertise from day one – and watch how smooth it can actually be.

That’s the gap I fill for medical device founders:

Not replacing your technical team. Not over-engineering your submission with $200K Big Consulting bloat.

But providing strategic regulatory guidance at the critical decision points – before you waste six months assuming you don’t need biocompatibility testing, before you commit to an aseptic sterilization claim you can’t support, before you learn the hard way that scientific expertise and regulatory strategy are two completely different skill sets.

I became a regulatory consultant because I had to. Now I help founders skip that expensive education.”

Moral of the story?

“My biggest mistake? Listening when my science team said we didn’t need regulatory consultants – that they’d just rip us off.

Turns out, the ‘expensive’ consultant I resisted would have saved us over a year and six figures in mistakes.

I learned the hard way: in medical device development, regulatory strategy isn’t optional. And confidence without regulatory knowledge is the most expensive assumption you can make.”