LDTs have been the object of lots of attention by the regulators world-wide and this because every day thousands of patient-impacting IVD results are delivered to physicians obtained by products and technologies which are outside the official regulatory pathways. In USA LDTs are a gray area from an FDA enforcement perspective. FDA has decided that it will use enforcement discretion when dealing with these testing services. This session discusses the pathway for taking an LDT into the regulated environment of In Vitro diagnostics based on real-world data and presents the unique solution adopted by the EU regulators in the EU IVD-Regulation for dealing with LDTs. This session discusses the pathway for taking a Lab developed test (LDT) into the regulated environment of In Vitro diagnostics based on a real-world case study. In USA, LDTs are often regulated under CAP/CLIA requirements as the testing service is typically performed in a reference laboratory. This case study will walk participants through the challenges that come with moving from CAP/CLIA to QSR, such as, QMS differences, regulatory submissions, Organization changes, reporting requirements, impact on global market entry, introduction of design control, and risk management activities. Participants will gain an understanding of the pitfalls and opportunities when building a strategy to transition their LDTs into a more complex regulatory environment that covers both USA and Europe.
Describe the difference between CAP/CLIA and QSR.
Explain the unique approach of the EU IVD-R for LDTs and how this may represent a major restriction of the LDT practice in the EU.
Discuss how to build a company transition strategy both in USA and in Europe.