FDA Guidance on RUO (Research Use Only)/IUO (Investigational Use Only) Products 2015

Topics

• Research Use Only (RUO) In Vitro Diagnostic Products
• FDA Requirements for Research Use Only and Investigational Use Only IVD Products
• Appropriate Labeling and Distribution Practices for RUO and IUO Products
• Investigational Use Only (IUO) In Vitro Diagnostic Products
• Investigational Use Only Labeling
• Research Use Only Labeling
• Instructions for Use of an IVD Product Labeled RUO or IUO
• Distribution Practices that are Inconsistent with RUO/IUO Designations
• Other Relevant Practices
• Validation and Verification of Clinical Diagnostic Testing Using IVD Products Labeled RUO or IUO
• Software Labeled RUO or IUO
• Use of a Certification Program
• FDA’s Compliance Approach

Who should Attend

• R&D managers and staff
• Senior management
• Laboratory personnel
• Pathology staff
• Clinical staff
• Production managers
• Customer support staff
• Marketing staff
• Quality assurance staff
• Regulatory staff