In Vitro Diagnostics
Geographic Coverage: North America,
Learning Level(s): Intermediate: Content is appropriate for individuals who have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s)., Advanced: Content is intended for individuals who are well-versed in most/all concepts associated with the topic(s).
SessionType: Featured session
The development of genetic testing, the globalization of economic market and internet have opened the door to a worldwide market for US-based laboratories. For a few years the regulation on those labs and their LDTs remained blurry and vague, today the FDA and now the European Union have developed regulations to protect customers interested by those products. This session will discuss the state of the regulation on both side of the Atlantic and explain how those converge, but also identify the points of divergence between the US and EU requirements. Participants will learn how to determine which requirements are applicable to their labs and how to integrate new requirements with the least disruption to their day-to-day operations.
This presentation will also allow managers of CLIA labs, which may not be aware of the new EU regulation, to learn and to prepare for the deadline of May 2022.