FDA Guidance on RUO (Research Use Only)/IUO (Investigational Use Only) Products 2015 is a webinar that covers topics such as:
- 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
FDA Guidance on RUO (Research Use Only)/IUO (Investigational Use Only) Products 2015 is intended for:
- 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