Module 15 Presentations

15/04/2024

IDE Requirements (21 CFR 812)

21 CFR 812.1: “An approved investigational device exemption (IDE) permits a device that otherwise would be required to comply with a performance standard or to have premarket approval to be shipped lawfully for the purpose of conducting investigations of that device” An IDE is a regulatory submission that permits clinical investigation of devices • Describes applicability of the IDE regulations • Provides administrative information

• Outlines the contents of the IDE application • Describes FDA actions on IDE applications • Assigns responsibilities to participants

The Organisation for Professionals in Regulatory Affairs

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When a Device IDE Exemption is Exempt Process can be a little confusing with exemption and exempt used All medical devices used for investigations apply 21 CFR 812

What does the process look like in Europe for investigational device

Investigational Device

Non Significant Risk Device

Significant Risk Device

Each Country Planned

Ethics Committee Approval

Health Authority Approval

IRB Approval

IDE Approval

Clinical Study

Clinical Study

The Organisation for Professionals in Regulatory Affairs

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