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Guidance
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.
Guidance

Non-Significant Risk (NSR) Medical Devices: Monitoring Requirements

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Guidance
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.
Guidance

Waivers and Alterations under OHRP, FDA and HIPAA

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Guidance
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.
Guidance

Informed Consent Procedures Using Electronic Systems and Remote Use of Paper Documents

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Guidance
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.
Guidance

Emergency Research (Planned and Approved) with Exception from Informed Consent

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Guidance
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.
Guidance

FDA guidance – General, Drug and Biologicals, Medical Devices, and FDA operations

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Guidance
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.
Guidance

Humanitarian Use Device Requirements for U-M Physicians & Investigators

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Guidance
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.
Guidance

Emergency Use of a Test Article in Life-Threatening Circumstances

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Guidance
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.
Guidance

FDA Expanded Access Program at the University of Michigan

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