In order to legally market a medical device in the United States, medical devices must be reviewed by the Food and Drug Administration (FDA), the agency responsible for protecting the public health by overseeing medical products. The Medical Device Amendments of 1976 gave the FDA the primary authority to regulate medical devices and required the FDA to obtain “reasonable assurance of safety and effectiveness” before marketing.
With the unprecedent challenges related to the application of the new In Vitro Diagnostic Regulation (IVDR – EU 2017/746) in Europe, manufacturers are facing a new dilemma with regards with their business strategy. One of the most often asked question is around the choice of the first market entry and the optimization of the efforts required to building up technical data that can be used for both EU and US regulatory compliance.
Additionally, within the last years, the strong increase of laboratory-developed tests (LDTs) have led to increased scrutiny of these diagnostic tests. FDA has issued draft guidance that describes the enforcement discretion for certain regulatory requirements, certain types of LDTs and providing inputs on the transition timelines based on the risk of devices. This triggers questions and uncertainties among manufacturers and laboratories that develop LDTs when it comes to their future and compliance with IVD regulations in the US.
In this regard, a deep understanding of both EU and US regulations and of the related analytical and clinical requirements is a must to set up a strong and optimal strategic roadmap specific to each IVD device.
.png)
