Co-Op @ Apnimed | Ex-Pfizer & Syneos | MS Regulatory Affairs @ Northeastern | Biologics & Biosimilars | Medical Devices
📊 Did you know? Only about 50-60% of de novo submissions to the FDA's Center for Devices and Radiological Health (CDRH) receive authorization. Here's what medical device innovators need to know: 🔬 De Novo Demystified: These submissions are for novel, low to moderate risk devices without predicates They're challenging because reviewers often encounter unfamiliar technologies 🚀 Boosting Your Chances: Leverage pre-submission consultations Obtain an Investigational Device Exemption (IDE) Clearly articulate your product's story, target patients, and risk-benefit profile 💡 FDA's Perspective: Balance benefits and risks (not zero risk) Evaluate based on intended use, patient population, and acceptable uncertainty Empower staff to make decisions with some level of uncertainty 🗣️ "Companies who come in with a pre-submission before their de novo do better." - Owen Faris, Principal Deputy Director at CDRH's OPEQ 🔑 Key Takeaway: Engage early and often with the FDA. A well-prepared de novo submission, backed by solid data and clear communication, significantly improves your chances of success. #MedicalDevices #FDA #RegulatoryAffairs #Innovation #HealthcareTech
