Basic research in Proteomics has led to new understanding of proteins’ contributions to health and disease, and has also driven the advancement of powerful analytical technologies used to explore these contributions.  Translating these discoveries and technologies into in vitro diagnostic (IVD) tests presents expanded opportunities to improve patient care; however, the complexity of these technologies raises challenging questions on how to evaluate the safety and effectiveness of these tests.  Fundamental to using IVDs in the clinic is the demonstration that the tests are safe and effective—that the results claimed are accurate and precise and that the clinical interpretation of the results is supported by science.  The more complex the information gathered, the more challenging is the validation of results; therefore,  FDA will discuss the elements of clinical and analytical validation of IVDs and proteomic technologies the successful transfer of research and discovery-level assays into the clinic.