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Humanitarian Use Device Requirements for U-M Physicians & Investigators
Non-Significant Risk (NSR) Medical Devices: Monitoring Requirements
Emergency Research (Planned and Approved) with Exception from Informed Consent
Emergency Use of a Test Article in Life-Threatening Circumstances
Waivers and Alterations under OHRP, FDA and HIPAA
Informed Consent Procedures Using Electronic Systems and Remote Use of Paper Documents
FDA guidance - General, Drug and Biologicals, Medical Devices, and FDA operations
University of Michigan Medical School Policy on Requirement to Use MICHR MIAP Services
FDA Expanded Access Program at the University of Michigan
Statement of Practice: Sections 15 and 16 of IRB Application