Resources for Compliance with FDA Regulations

For:

Online Course: 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.

Access this course.

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).

Access this guidance.

IND Decision Worksheet

This worksheet is intended as an exercise to help U-M investigators determine whether an IND may be required before initiating a new clinical study. This document can be provided to the IRB in support of an e-Research application prior to initiating an investigator-initiated clinical trial.

Access this worksheet.

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).

Access this guidance.

IDE Decision Worksheet

This worksheet is intended to help U-M investigators determine whether an IDE is required for FDA/IRBMED approval before initiating your investigator-initiated medical device clinical study. This document can be provided to the IRB in support of an eResearch application before initiating an investigator-initiated medical device clinical study.

Access this worksheet.