IDE Decision Worksheet

Overview

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).

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.


Downloads

FDA Guidance - Significant Risk & Nonsignificant Risk medical device studies.pdf

IDE Decision Worksheet.pdf


Questions and Disclaimer

Resources on this page may not be an exhaustive list. If you know of other resources in this category, please let us know using the "Suggest a Resource" link at the bottom of the page.

Was this article helpful?

Can’t find what you’re looking for?

Subscribe to Breakthrough, MICHR’s monthly e-newsletter