FDA Requirements for Investigational Device Exemption (IDE)
The FDA’s Investigational Device Exemption (IDE) allows the investigational use of a medical device in clinical studies to gather essential safety and effectiveness data required for premarket approval (PMA) or clearance.
To obtain an IDE, a sponsor must submit an application to the FDA that includes:
✅ Study Protocol – A detailed plan outlining the investigation.
✅ Risk Analysis – Assessment of potential risks based on device classification.
✅ Investigator Qualifications – Ensuring expertise and compliance with study requirements.
✅ Informed Consent Documents – Protecting participant rights and ensuring ethical conduct.
✅ Device Design Details – Comprehensive technical specifications of the investigational device.
Throughout the study, sponsors must adhere to strict monitoring, reporting, and compliance requirements, including:
🔹 Reporting adverse events promptly.
🔹 Maintaining detailed study records.
🔹 Ensuring ethical patient safeguards.
🔹 Generating reliable clinical data to support regulatory decisions.
Our Services
🔹 Device Classification & Approvals
🔹 Providing Risk Analysis for Medical Devices (ISO 14971:2019)
🔹 Preparing the Research Protocol
🔹 Support Through IRB Approvals
🔹 PMA Documentation
🔹 FDA 510(K) Documentation
🔹 CFR 21 (Part 812) Documentation
🔹 Monitoring Product Safety
🔹 Application Submission