The New LDT Guidance

  • Duration: 60 mins.

Price: $69.00

Member Price: $59.00

This is a recorded version of an AACC live webinar that was held September 10, 2014. The Food and Drug Administration (FDA) issued its long-awaited draft guidance on Laboratory Developed Tests in 2014. The FDA proposes to adopt a risk-based approach that will have wide-ranging implications for all laboratories developing and utilizing LDTs. Low-risk LDTs will be subject to registration, listing and medical device reporting requirements, while high- and moderate-risk LDTs will need to meet more extensive requirements, including seeking premarket approval or clearance.

This 60-minute webinar with the Director of the FDA?s Office of In Vitro Diagnostic Devices is a comprehensive explanation of how the agency proposed to regulate LDTs and what it will mean for your lab and its ability to perform LDTs.

Issues discussed include:

  • How this plan will affect molecular testing and other cutting edge tests
  • What data labs will need to provide for new and existing LDTs
  • What constitutes a modification to an LDT and agency requirements
  • The data needed for registering and listing an LDT
  • What is considered an adverse event and the laboratory?s responsibilities for reporting it
  • What LDTs will be subject to lesser oversight
  • The various phase-in periods for compliance

A Q&A session from the live webinar is also included on the recording.