Dr Sally A. Hojvat

Dr. Hojvat is an independent consultant, currently a part time advisor for the WHO pre-qualification team and for Partners in Diagnostics, LLC. Regulatory Consulting to Advance Global Health. She is consulting on the global regulation pre- and post-market introduction of in vitro diagnostics to International public health agencies such as FDA and WHO, for procurement organizations, for regulatory harmonization efforts, governmental bodies and philanthropic foundations.

Dr. Hojvat was for 12 years the Director of the Division of Microbiology Devices, Office of In-vitro Diagnostic Device and Radiological Health (OIR), CDRH, Food and Drug Administration, (FDA), where she was responsible for the review and evaluation for safety and effectiveness of all IVD microbiology devices (reagents, software and instruments) submitted to the FDA for pre-market device clearance/approval/CLIA waiver and emergency use authorization among other responsibilities. She represented FDA on the President’s Committee for anti-microbial resistance and on several U.S Health and Human Services emerging pathogen preparedness committees.

Prior to work at the FDA, Dr. Hojvat spent 19 years in the international diagnostic device industry in various capacities ranging from device R & D, Manufacturing and Clinical Research. Since she retired from the FDA in 2015, her work has been mostly dedicated to reviewing and editing for the WHO IVD Prequalification Team, PQ dossiers and new guidance documents for IVD manufacturers/reviewers on a variety of pre-market /post-market infectious disease and other disease markers in vitro diagnostic device topics. Advising on requirements for dossiers submitted to the WHO PQ program such as for HPV, Ebola, Zika and Malaria. She has also served on a U.S. Academy of Science Committee related to microbial diagnostic issues, participated in regulatory training workshops in Africa and Asia and worked with the Gates Foundation and other international non-profit agency grant proposal review teams. She is author and co-author of major publications and has FDA Awards at the FDA Commissioner/Center Level, including the FDA Award of Merit in 2015 and Abbott Lab. Awards (1984-2003) including 2 Presidential Awards.