In his final days in office, former President Joe Biden released several Food and Drug Administration (FDA) guidance documents addressing such areas laboratory-developed tests (LDTs), artificial intelligence (AI) in healthcare, and equitable device performance.
- The LDT guidance involved the validation of LDTs during public health emergencies and managing the outbreaks of emerging pathogens.
- The FDA released two guidance documents on AI, providing a framework for AI-enabled devices and its use in drug and biologic development. The documents emphasize addressing bias, provide recommendations for real-world data (RWD) usage, and outlines potential avenues for stakeholders to contribute to evidence generation to enhance research efficiency.
- Another new guidance issued is aimed at addressing product shortages to mitigate disruptions in the supply of diagnostic reagents and devices. Additionally, updated safety protocols for tissue and cell products outline measures to reduce risks of disease transmission, ensuring compliance and patient safety in laboratory processes.
As these policies evolve, laboratories are positioned to play a pivotal role in advancing equity, innovation, and preparedness. ADLM will continue to monitor these developments and advocate for policies that empower laboratories to enhance patient care and drive innovation in healthcare.
