Back to: FDA Regulatory Education for Industry (REdI) 2024 Conference – Biologics Track
Presenter
Julia Tait Lathrop, PhD
Associate Deputy Director
Division of Emerging and Transfusion-Transmitted Diseases (DETTD)
Office of Blood Research and Review (OBRR)
Center for Biologics Evaluation and Review (CBER)
US Food and Drug Administration (FDA)
Julia Tait Lathrop, PhD is the Associate Deputy Director in the Division of Emerging and Transfusion-Transmitted Diseases (DETTD), Office of Blood Research and Review (OBRR) in the Center for Biologics Evaluation and Review. DETTD has responsibility for regulating retroviral diagnostics, including all HIV devices, as well as devices for screening blood donors for infectious disease. In her current position Dr. Lathrop is responsible for developing and implementing regulatory and review policies for the Division. She joined FDA in 2012 and held roles in the Center for Devices and Radiological Health (CDRH), Office of In Vitro Diagnostics and Radiological Health (OIR, now OHT7) as a Scientific Reviewer and as Acting Chief of the Immunology and Flow Cytometry Branch in the Division of Immunology and Hematology Devices until 2016, when she joined DETTD. She holds a Ph.D. in Biology from the University of Virginia.
Abstract
Julia Lathrop from FDA’s CBER discusses the regulation of HIV diagnostic devices, noting CBER’s role in overseeing tests for transfusion transmitted infections and all HIV tests, stemming from the historical contamination of the blood supply. The presentation traces the history from the first reports of AIDS in 1981 and the discovery of HIV in 1984 to the licensing of the first donor screening test. FDA evaluates in vitro diagnostics by balancing the benefits and risks, primarily considering the risks of a wrong result to the patient. Device classification (Class 1, 2, 3) is based on these risks and the ability to mitigate them using general or special controls, rather than the inherent seriousness of the condition being tested for. After extensive experience, FDA has reclassified many HIV diagnostic tests from Class 3 to Class 2, a process finalized in 2022. This reclassification aims to accelerate market entry and reduce costs for manufacturers, thereby increasing the availability of safe and effective devices. While most HIV IVDs are now Class 2 devices requiring a 510(k) submission, self-tests and self-collection devices remain Class 3 requiring PMAs, although the FDA is streamlining their review process. The agency encourages the development of novel HIV diagnostic devices and works to improve access to testing.