NSR Device Self-Audit (Word version)

Topic

Self-Assessement

Type

The purpose of this self-assessment is to help researchers assess whether they’re meeting their regulatory obligations and institutional guidance for Non-Significant Risk Devices.

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Information

The University of Michigan has an approved Federalwide Assurance (FWA) with the U.S. Department of Health & Human Services (HHS). U-M’s IRBs are also registered with the HHS Office for Human Research Protections (OHRP).

U-M FWA Number: FWA00004969
U-M Institution/Organization Number: IORG0000144

Expiration dates for assurance changes regularly. If you need the expiration date, visit OHRP’s registration database, enter the FWA Number above, and click “Search.”

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