Module 15 Presentations

15/04/2024

FDA Guidance Helps Clinical Strategic Thinking: Frame Supporting, Clinically Applicable Data Early Feasibility (including IDE) Assistance • Clinical study before the device design has been finalized, for a specific

indication, which may guide device modifications Small first in human (FIH) 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

No formal method exists in the EU

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

The Organisation for Professionals in Regulatory Affairs

27

Other Considerations

The Organisation for Professionals in Regulatory Affairs

28