Laboratory Developed Test Manufacturers in the U.S.

Watch now: Laboratory developed test manufacturers in the U.S.

Watch this webinar to learn how to navigate laboratory-developed test manufacturers in the U.S.

Webinar date

Mar. 28, 2024

Speaker

Dr. Oliver Eikenberg, lead consultant QA/RA

Diagnostic testing is a cornerstone of every modern medicine and given the role these IVDs play in modern medical care, their safety has a significant impact on public health.

The U.S. Food and Drug Administration (FDA) has long considered an LDT to be an IVD under enforcement discretion (controlled by CLIA) but intends with the new proposed rule to phase out this status in the future. The FDA’s proposed rule regarding LDT is aimed at helping to increase the safety and effectiveness of LDTs. What this could mean for the future role of laboratories acting as manufacturers will be discussed in this webinar.

This webinar will help you get a deeper understanding of the history and recent concerns raised by the FDA and the proposed controls for the future regulation of LDTs in the U.S. The presenter will discuss scenarios and resulting actions for the expected phase out policy and timeline.

About the presenter

Dr. Oliver Eikenberg, lead consultant QA/RA

Dr. Oliver Eikenberg has over 23 years of medical device regulatory experience combined with more than 15 years of technical hands-on experience in IVD device development, manufacturing, and product management. Eikenberg’s background as a chemist with a Ph.D. in analytical chemistry, combined with many years developing and producing immunoassays and genetic tests, informs his detailed level of expertise in in vitro diagnostic devices. Over the last few years, he was handling projects for more than >200 Technical Documentations reviews (EU) for high-risk up to low-risk IVD, including but not limited to SARS-CoV-2, PSA, HIV, TORCH, Alzheimer’s Disease markers, autoimmune markers, cancer markers, companion diagnostics and more.

In his role as lead consultant QA/RA, he focuses on medical device regulations in the EU, AUS and the U.S. He has managed several 510(k) submissions, performed 513(g) requests and Q-Sub (Pre-Sub) meetings with the U.S. Food and Drug Administration (FDA). His competence further includes audits on quality management systems, where he went through numerous ISO 13485 Notified Body audits and 21 CFR part 820 FDA inspections. He also acts as an internal auditor for Emergo by UL customers selling in Europe.