Resources for Compliance with FDA Regulations

A collection of resources that guide compliance with FDA regulations

What is this resource?

Online Course on Investigational New Drug (IND) and Investigational Device Exemption (IDE) Orientation Module
This self-guided course is designed to introduce you to regulatory responsibilities of sponsors and investigators of drug and device studies.

IND Resources
FDA Guidance – Determining Whether Human Research Studies Can Be Conducted Without an IND
This guidance is intended to assist clinical investigators, sponsors, sponsor-investigators, and institutional review boards (IRBs) in determining whether research studies involving human subjects require an Investigational New Drug application (IND).

IDE Resources
FDA Guidance – Significant Risk and Nonsignificant Risk Medical Device Studies
This guidance is intended to assist clinical investigators, sponsors, sponsor-investigators, and institutional review boards (IRBs) in determining whether research studies require an Investigational Device Exemption (IDE).

How this advances translational science

Implementing operations that facilitate and support the quality and impact of research