Review of FDA-Regulated Research Policy

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Applicable HRPP Policy

• Control of Test Articles Used in Research Policy
• Clinical Trials Registration & Results Reporting
• Emergency Use of Test Articles and of Humanitarian Use Devices Policy
• Exempt Research
• Humanitarian Use Device Policy

Attachments and Other References

• Guidance on FDA Regulation of Medical Mobile Apps
• Guidance on Requirements by the FDA for the Investigator as a Sponsor
• Investigational Software Guidance