Sally Hojvat ,M.Sc., Ph.D. is currently an advisor for Partners in Diagnostics, LLC , the WHO and their IVD pre-qualification team and is consulting on the global regulation pre-and post-market introduction of in vitro diagnostics both for emergency and non-emergency use for procurement organizations, in-vitro diagnostic test developers, governmental bodies and for philanthropic foundations. She was for 12 years the Director of the CDRH Division of Microbiology Devices in the Office of In-vitro Diagnostic Device and Radiological Health at the U.S. Food and Drug Administration, (FDA) and prior to that spent 19 years in the international diagnostic device industry in various capacities ranging from R & D, On-Market Product Support, Scientific Affairs , Quality and Clinical Research. She represented FDA on the President’s Committee for anti-microbial resistance , served on several U.S Health and Human Services Emerging Pathogen Preparedness Committees, as well as a U.S. Academy of Science Committee related to microbial diagnostic issues. Dr Hojvat has participated in IVD regulation training workshops in Europe, Africa and Asia and worked with international non-profit agency grant proposal review teams. She was also a member from 2017-2019 of the 1st WHO Strategic Advisory Group of Experts on in Vitro Diagnostics responsible for the selection and use of “Essential IVDs”. She is author and co-author of several major publications.
Current role