In vitro diagnostic (IVD) products drive a significant portion of clinical decision making today. IVDs assist in the identification, diagnosis and monitoring of disease. They play an ever-expanding role in the selection of appropriate therapeutic interventions in the delivery of healthcare with the advent of personalized medicine. These key products are a distinct class of medical devices regulated in the US by the Food and Drug Administration (FDA).
This course provides an overview of in vitro diagnostic medical devices––focusing on FDA’s regulatory requirements. It introduces key regulations and guidelines necessary for effective product development, explains what IVDs are, and describes development and testing, getting a product to market, product review and FDA submission requirements.
Learning Objectives
Upon completion of the course, participants should be able to:
- Discuss the current state of IVD regulations in the US and other regions
- Identify and explain areas of IVD regulations related to:
- Product classification
- IVD development, testing and premarket submission
- Postmarket maintenance and considerations for product end users
- Identify potential future challenges facing IVD manufacturers
- Discuss IVD technologies and emerging trends
- Apply IVD-specific regulations and guidelines for successfully traversing regulatory hurdles
Target Audience
This is an introductory course designed for new and experienced regulatory professionals interested in learning the basics of in vitro diagnostic medical devices regulations.