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 Diagnostic Regulation (IVDR 2017/746), it’s crucial that diagnostics businesses critically evaluate their entire supply chain to close any gaps and ensure IVDR-compliance can be maintained throughout the device lifecycle. An important question to ask is whether outsourcing your IVD projects will help or hinder your efforts to comply and remain competitive in this shifting regulatory landscape. In the final blog of this 2-part series, we consider the advantages of partnering and the factors that are crucial for success.
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 satisfy the requirements of, for example, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).
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 laboratories, their industry partners that produce the reagents, assays, and instruments needed to perform these tests, and the clinicians and patients who have come to rely on LDTs to fill the gap in diagnostic testing.
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 LDTs are regulated by FDA's Clinical Laboratory Improvement Amendments (CLIA), is creating much uncertainty and not a little distress. What would this significant change mean for laboratories that already rely on LDTs, are improving existing tests and actively developing new ones?
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 U.S. Food and Drug Administration's (FDA) stated plan to issue a new guidance that would change the paradigm for regulating LDTs.