Amidst a significant reorganization of the Center for Devices and Radiologic Health (CDRH), Tim Stenzel MD PhD becomes head of the Office of In Vitro Diagnostics and Radiological Health (OIR).
See an August 6, 2018, article at NAMSA (here) and an August 9, 2018, article at MedTech Insight (subscription; here.)
The position had an acting director since Alberto Gutierrez PhD stepped down in Summer 2017. Both Gutierrez and his predecessor, Dr. Steve Gutman, had been long time FDA employees and thus internal promotions to director.
Stenzel is a graduate of Duke's MD/PhD, pathology residency, and molecular genetics fellowship. He worked successively at Abbott, Asuragen, Quidel, and InvivoScribe where he was Chief Operating Officer 2014-2018.
For a full description of the CDRH reorganization, including OIR, see NAMSA here. See also a 21-page FDA deck on the re-org, archived at Advamed, here.
Stenzel gives a 12 minute presentation, in his prior role at Invivoscribe, at the Personalized Medicine World Conference in January 2018, here (minutes 1-13).
In other FDA diagnostics news, the FDA recently provided the Hill with what is being described as nearly an FDA plan for legislative reform of diagnostics at FDA; for more see here.
Steve Gutman was director 1993-2009; Alberto Gutierrez 2009-2018. Stenzel is only the 3rd director in the division's 25-year history.