Following years of discussion and debate, the FDA officially published its final rule covering laboratory developed tests (“LDTs”) on May 6, 2024....
On November 17, 2023, FDA published a new guidance document titled “Assessing the Credibility of Computational Modeling and Simulation in Medical...
The introduction of new and complex regulations, combined with the need to get safe and effective devices approved and into the market as quickly and...
The new European Union Medical Device Regulation ("EU MDR") represents one of the most significant and impactful regulations within the medical...
