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

Why Should You Attend:

FDA is concerned that the distribution of unapproved and uncleared IVD products labeled RUO or IUO, but intended for purposes other than research or investigation (for example, for clinical diagnostic uses), has led, in some cases, to the clinical diagnostic use of products with unproven performance characteristics, and with manufacturing controls that are inadequate to ensure consistent manufacturing of the finished product. Use of such tests for clinical diagnostic purposes may mislead healthcare providers and cause serious adverse health consequences to patients, who are not aware that they are being diagnosed with or treated based on the results of tests with research or investigational products.

This webinar will offer best practices for protecting patients from unauthorized use of RUO and IUO products and conforming to FDA requirements for marketing RUO and IUO products. The course will also highlight distribution practices that are inconsistent with RUO/IUO designations and FDA’s compliance approach among other key discussions.

Learning Objectives:

• Protecting patients from unauthorized use of RUO and IUO products
• Conforming to FDA requirements for marketing RUO and IUO products
• Using adequate practices for RUO and IUO products
• Avoiding manufacturing defects

Areas Covered in the Webinar:

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

Who Will Benefit:

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

Instructor Profile:

Dev Raheja, MS,CSP, author of the books Preventing Medical Device Recalls and Safer Hospital Care, is an international risk management, patient safety and quality assurance consultant for medical device, healthcare and aerospace industry for over 25 years. Prior to becoming a consultant in 1982, he worked at GE Healthcare as supervisor of quality assurance/manager of manufacturing engineering, at Cooper Industries as chief engineer, and at Booz-Allen & Hamilton as risk management consultant for a variety of industries.

His clients include Johnson & Johnson, Siemens Medical Systems, Medtronic, Carl Zeiss, Warner-Lambert, Zimmer Holdings, and DuPont. He has served as adjunct professor at the University of Maryland for five years for its PhD program in reliability engineering. He is a Fellow of American Society for Quality and recipient of its Austin Bonis Award for Reliability Education Advancement, former chair of the Reliability Division, and member of the Biomedical Division. He is a senior member of IEEE. Currently, Mr. Raheja serves as an adjunct professor at the Florida Tech for its BBA degree in healthcare management, and has authored two more books - Assurance Technologies Principles and Practices; and Zen and the Art of Breakthrough Quality Management. He has received several industry awards including the Scientific Achievement Award and Educator-of-the Year Award from the System Safety Society. He is a former National Malcolm Baldrige Quality Award Examiner in the first batch of examiners. He serves on the Patient and Families Advisory Council at Johns Hopkins Hospital and is a member of American College of Healthcare Executives.

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