Director, OHT7: Office of In Vitro Diagnostics and Radiological Health, Office of Product Evaluation and Quality
Dr. Timothy Stenzel, MD, PhD directs the FDA’s Office of In Vitro Diagnostics and Radiological Health
(OIR, CDRH) and has an extensive background, spanning more than 20 years, in executive leadership,
innovation, companion diagnostics, research and development, FDA regulations, and clinical laboratory
operations. He received his M.D. and Ph.D. in Microbiology and Immunology from Duke University.
Following a residency at Duke University, Tim created Duke’s Clinical Molecular
Diagnostics Laboratory and served as Director, Clinical Molecular Diagnostics and Medical Director,
Cytogenetics. He is board certified in Molecular Genetic Pathology and Anatomic and Clinical Pathology.
From 2014 to 2018 when he joined the FDA, Tim served as COO at Invivoscribe and during his industry
career he played important roles in the development and launch of more than 30 In Vitro Diagnostics
products, as well as numerous unique LDTs, including an FDA approved companion diagnostic.
Other experience includes Chief Scientific Officer and founder of the Molecular
Diagnostics franchise at Quidel, Chief Medical Officer and VP of Research and
Development at Asuragen, Senior Director for Medical, Regulatory and Clinical Affairs at
Abbott Molecular, a Board Director at the ACMG Foundation for Genetic
and Genomic Medicine, the ACMG/CAP Biochemical and Molecular
Genetics Resource Committee, the AMP Finance Committee, the
AMP Strategic Planning Committee, as AMP Chair-Elect and Chair of the Solid
Tumor Division, the CAP Molecular Oncology Committee, and as an elected
Member of the CAP House of Delegates.
As the OIR Director, Tim advises FDA leadership on all regulatory matters (pre-market and post-market) for in
vitro diagnostics, radiological medical devices, and radiation-emitting products that have an impact
on Center and Agency level decisions, policy development, nationwide program execution and short and
long-range program goals and objectives as well as provide executive leadership and scientific direction
to the OIR staff.
Monday, September 27, 2021
4:00 PM – 5:00 PM ET
Tuesday, September 28, 2021
11:15 AM – 12:15 PM ET