NAMSA’s Post

In 2025, ASCA-accredited biocompatibility submissions had a deficiency rate of just 5.1% — down from ~37% during the pilot phase. Here's what's driving it: → ASCA testing is pre-vetted by FDA against consensus standards → In eSTAR, ASCA submissions collapse pages of required fields to 3 actions per endpoint → Fewer Additional Information (AI) requests, faster prep, stronger regulatory record NAMSA was the first U.S. lab to earn ASCA accreditation in 2021 and remains the only one accredited for the full panel of eligible test methods. Only 5 biocompatibility labs worldwide hold active ASCA accreditation today. If biocompatibility is on your 510(k) critical path, this one's worth reading. 🔗 https://lnkd.in/gSWcvqbS #MedicalDevices #510k #Biocompatibility #ASCA #RegulatoryAffairs #eSTAR #NAMSA