IDE Decision Worksheet


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.


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

IDE Decision Worksheet.pdf

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