Unlocking U.S. Clinical Studies: A Deep Dive into 21 CFR Part 812

Medical Device Global Market Access

This episode demystifies the U.S. FDA's 21 CFR Part 812 regulation for Investigational Device Exemptions (IDEs). We explore the purpose of an IDE, the critical differences between significant and non-significant risk device studies, and the corresponding regulatory requirements for sponsors, investigators, and IRBs to ensure compliance during clinical trials. Key Questions: • What is an Investigational Device Exemption (IDE) and when is it required? • How does the FDA classify devices as Significant Risk (SR) versus Non-Significant Risk (NSR)? • What are the different approval pathways for SR and NSR device studies? • Who is responsible for determining the risk level of an investigational device? • What are the essential responsibilities of a sponsor during an IDE study? • What specific labeling is required for an investigational device? • How do regulations for informed consent and IRB review apply to IDEs? • What are the reporting requirements for adverse events during a clinical trial? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.