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May 4, 2026
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.
April 27, 2026
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.
April 24, 2026
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.
April 23, 2026
Every major medical product safety disaster has a predictable anatomy. From thalidomide in the 1960s to Vioxx in the 2000s, from Avandia to recent issues with JAK inhibitors, ranitidine, and opioids, the pattern is the same. It’s not that the science was missing – often the safety signals were there – but the system refused to be accountable to the science. In each case, warning signs existed, yet no one owned the obligation to act on them. This uncomfortable truth underpins why simply getting “better data” isn’t enough: safety advice only matters when someone is accountable to enforce it.
