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long-awaited draft guidance on Laboratory Developed Tests in 2014.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
- 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.