Albrecht Stenzinger: How to Navigate the Regulatory Environment for Diagnostic Testing in the EU and the US?

Albrecht Stenzinger, Head of the Molecular Pathology Center (MPZ) and Deputy Director of the Institute of Pathology at Heidelberg University Hospital (UKHD), shared a post on LinkedIn about a paper he co-authored with colleagues published in ESMO Open:

“As a healthcare provider HCP, have you ever wondered how to navigate the regulatory environment for diagnostic testing in the EU and the US?

Have you ever wondered about terms such as IHIVD, LDTs, CLIA, IVDR, EMA, and FDA in this context?

How do regulatory ecosystems influence innovation and patient safety?

Need some guidance, reflections, and thoughts on further developments?

Find out what it’s all about in our latest work published in ESMO Open.

Kudos to a great team.”

Title: Regulation of laboratory-developed tests and in-house in vitro diagnostic medical devices in the United States and the European Union – a comparative overview

Authors: A. Kahles, A.-L. Volckmar, H. Goldschmid, M. Salto-Tellez, M. Vogeser, J. Stone, M. Brüggemann, J. Budczies, D. Kazdal, R. Salgado, P. Schirmacher, S. Peters, J.K. Lennerz, and A. Stenzinger

You can read the Full Article in ESMO Open.

More posts featuring Albrecht Stenzinger.