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

MIAP-IDE Decision Worksheet_rev_03-14-2019.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.

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