James Mullally, Ph.D.

James Mullally, Ph.D.

Vice President, In-Vitro Diagnostic Regulatory Affairs

Dr. Mullally specializes in FDA interactions and strategy, development of regulatory submissions, medical and regulatory writing, review and analysis of pre-clinical and clinical data, design of clinical trials, regulatory review of marketing materials, and regulatory strategy for medical devices. He specializes in in-vitro diagnostic devices (IVDs), including companion diagnostic, therapeutic drug monitoring, continuous glucose monitoring, specimen collection (e.g. saliva collection), genetic tests, viral and bacterial infectious disease, hematology, and women’s health IVDs, as well as devices supported by point of care (POC), over the counter (OTC), or CLIA waiver studies.          


Dr. Mullally received his Bachelor and Master of Science degrees in Chemistry from Bridgewater State University, and his Ph.D. in Medicinal Chemistry from the University of Utah. He trained as a postdoctoral researcher in the laboratories of Dr. Keith Wilkinson, at Emory University, and Dr. Susan Michaelis at Johns Hopkins University, focusing on ubiquitin-mediated protein degradation.


Dr. Mullally was an Assistant Director in the Division of Chemistry and Toxicology Devices (DCTD) at FDA, where he led a team reviewing 510(k), de novo, IDE, PMA, 513(g), Qsub, breakthrough designation, and other submission types for a diverse in-vitro diagnostic device (IVD) portfolio: e.g. pharmacogenomic, preterm delivery, drugs of abuse, breath test, specimen collection, lead toxicology, and therapeutic drug monitoring. As part of FDA’s response to the COVID-19 pandemic, he volunteered to be reassigned to the Division of Microbiology Devices (DMD), and there led a team reviewing COVID-19 EUA devices. He previously served as a scientific reviewer in DCTD, where he conducted reviews of premarket (e.g. continuous glucose monitoring devices) and postmarket (e.g. recalls and complaints) submissions, and where he also served as the division’s instrument and software product specialist. He also served on several working groups, including the companion diagnostics working group, where he provided input on companion diagnostic device review policy at FDA. He was also the FDA representative for the SAMHSA Drug Testing Advisory Board, serving as a board member.

Prior to FDA, Dr. Mullally was a field application scientist, where he helped industry and academic clients design immunoassays to meet their research needs.

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