Regulatory Framework for In Vitro Medical Devices in the US E-Learning with WMDO

This course offers a clear and comprehensive view of the regulatory framework surrounding in vitro diagnostic (IVD) medical devices in the US.

Despite their technical recognition as a sub-class of medical devices, IVDs face different FDA expectations for pre- and post-market commercialization. This course provides detailed insight into this process, including applicable definitions, classification schemes, market trajectory, pre-market submissions, Clinical Laboratory Improvement Amendments (CLIA) categorization, quality system requirements, and post-market requirements for IVDs, as well as an introduction to the new sub-class of IVDs: companion diagnostics.

To enroll and purchase this course, please visit the WMDO website at: http://www.wmdo.org/SGS.aspx

Upon successfully completing this course, learners will be able to:

• Gain a comprehensive overview of IVDs with a focus on the FDA’s specific regulatory requirements, including drafts on companion diagnostics
• Grasp the essential regulatory requirements applicable to IVD regulations, which includes:
  • Product classification
  • IVD development and pre-market submissions
  • Quality Management Systems (21 CFR 820)
  • Post-market requirements
  • Proposed and current interactions with the FDA