A device that passes material inspection can still fail ISO 10993 biocompatibility testing — and understanding why the difference between a delay and a disaster is.
Kandih Regulatory Insights ·
The team thought this would be easy. The material was “medical grade.” The supplier had used it in healthcare for years. The device seemed simple enough, and the regulatory plan looked clean.
A founder imports a simple Class I medical device.
No electronics.
No software.
No implant.
No dramatic risk profile.
The supplier says, “This product has been sold for years.”
The customer says, “Send us your biocompatibility testing.”
Then the room gets quiet.
Your 510(k) Timeline Is Decided Months Before You File
Week seven of FDA review.
The email lands.
Subject: Additional Information Request
“Provide clarification regarding exposure assumptions relative to intended use.”
The toxicological risk assessment modeled once-daily adult use on intact skin.
The Instructions for Use allowed multiple daily uses across broader patient populations — including compromised tissue.
Harriet Kamendi, PhD, DABT I design FDA evidence that protects capital · Regulatory Toxicologist, PhD DABT · Medical Devices · Diagnostics · Drugs · Biologics · Medical Foods · Founder & CEO, Kandih BioScience There is a room where medical product development actually begins. It is not the GLP facility. It is not the pre-IND meeting […]
A founder says the company has a regulatory roadmap.
The slide looks polished.
The milestones look neat.
The dates seem aggressive, but still believable.
An investor flips through it and thinks one thing:
Can I trust this?
That is the real test.
The timeline looked brilliant. Prototype by June.Verification by September.FDA meeting by November.Submission next year. Clean. Sharp. Reassuring. Then reality showed up. One design change delayed testing.A risk issue changed the evidence plan.FDA feedback raised questions the team had not built for.Suddenly, the timeline that looked so certain started behaving like fiction. That is the problem […]
Everything looks fine until FDA responds. The roadmap is on track. The milestones are moving. The team is hitting deadlines. Then the feedback arrives. FDA wants clarification on intended use. The evidence does not fully support the claims. A design choice creates new questions about risk. The submission path no longer looks as simple as […]
A medical device company can look perfectly organized on paper and still be heading toward a regulatory mess. The timeline may look polished.Prototype by Q2. Verification by Q3. Submission next year. Investors feel reassured.The team feels productive.The board sees movement. Then one FDA meeting changes everything. The claims are too broad. The evidence plan is […]
An investor once asked a founder a simple question:
“What happens if FDA disagrees with your pathway?”
The room went quiet.
Not because the answer was confidential.
Because there was no answer.
The deal didn’t collapse immediately.
But it never recovered.
