Module 15 2022

19/05/2022

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. IDE regulation: • 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

23

Guidance that help clinical strategic thinking: Framing supporting, clinically applicable information Early Feasibility IDE: • Clinical study before the device design has been finalized, for a specific indication, which may guide device modifications Small first in human study (n = 10 to 20) • Safety is focus

Initial functionality, design iterations may be anticipated • May be expanded into Feasibility using IDE supplement as experience progresses • “…(used) when this information cannot practically be provided through additional nonclinical assessments.” • Design evaluation strategy (DES) table • Comprehensive planning (FMEA-like) document (cross-functional) • Interactions with FDA focus on DES as well as population & safety

https://www.fda.gov/m edia/81784/download

The Organisation for Professionals in Regulatory Affairs

24

12