Innovations in Skin Microphysiological Systems for Nonclinical Testing and FDA Modernization

Recent advancements in skin microphysiological systems (MPSs), driven by regulatory changes like the FDA Modernization Act 2.0, focus on alternatives to animal testing. This review discusses three key technologies—3D bioprinting, skin organoids, and skin-on-a-chip—that replicate human skin physiology for research and preclinical use. These platforms effectively model complex skin functions and disease phenotypes, aiding in toxicological screening and therapeutic evaluation. The review also considers how OECD test guidelines could support future validation and highlights the potential of automation and machine learning for scalable, high-content screening of skin MPS models.