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

  • 08 May 2015
  • Webinar

Description

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

Past Events

Important

Please, check "FDA Guidance on RUO (Research Use Only)/IUO (Investigational Use Only) Products" official website for possible changes, before making any traveling arrangements

Event Categories

Health & Medicine: Medical device, Pharma
Industry: Food & Beverages
Technology: Biotechnology

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