Most of the tests performed for patient care use automated colorimetric and immunoassay methods in the clinical laboratories. Clinical labs are regulated by CLIA and are routinely inspected by the College of American Pathologists. In local hospital clinical labs, all the machines and methods used are FDA cleared. There are numerous tests used in clinical practice which are not FDA cleared and have been developed by large reference laboratories. The methods used for these tests rely on technologies used for genomics, metabolomics, and proteomics areas of research. Mass Spectrometry is a powerful tool that is now commonly used in clinical laboratories and helps in making diagnosis of various diseases. Very few mass spec methods have been cleared by the FDA. The presenter recently attended a workshop held by the FDA and will present his experience and interactions in the workshop.