By Laura Nea
The global trend toward more stringent regulatory control of in vitro diagnostic (IVD) medical devices is sending shock waves through the industry. Now that we have passed the halfway mark in the transition to Europe’s new In Vitro...
By Severin Heynen
Successful scientific projects build on accurate results from analytical methods that you have confidence in. In regulated situations, they must be backed up by routines and documentation that follow regulatory standards that...
By Nicholas Smith
If the U.S. Food and Drug Administration (FDA) goes forward with its proposed guidance to regulate laboratory developed tests (LDTs) in the same way it does manufacturer-derived tests, then much is going to change for clinical...
By Nicholas Smith
The intention by the U.S. Food and Drug Administration (FDA) to issue a new guidance that would bring oversight of laboratory developed tests (LDTs) directly under FDA regulatory control, instead of the current paradigm in which...
By Nicholas Smith
Uncertainty and concern best describe the prevailing feelings of many researchers, clinicians, and companies that develop, manufacture, and implement laboratory developed tests (LDTs). The reason for all this uncertainty is the...