This webinar, led by Dr. Kim Sapsford of FDA’s Center for Devices and Radiological Health (CDRH), will provide an overview of regulatory requirements for sensor in vitro diagnostic devices at FDA, and a case study on a submission from a recently cleared in vitro nanotechnology-enabled sensor device.
Webinar viewers will be able to submit questions for the panelists to answer during the Q&A period. Questions can also be submitted to webinar@nnco.nano.gov a week prior to the date of the webinar through the end of the event.
Dr. Kim Sapsford is a premarket scientific reviewer at the Division of Microbiology Devices, Office of In Vitro Diagnostics and Radiological Health in the Center for Devices and Radiological Health (CDRH) at FDA. Recently she has been helping coordinate the FDA’s Emergency Use Authorization (EUA) of in vitro diagnostics for the recent Ebola outbreak in West Africa. Prior to transitioning to the premarket review side of FDA in 2013, she was Leader for the Laboratory of Emerging Biosensors and Biotechnology in the Office of Science and Engineering Laboratories, CDRH, FDA where a portion of her research and regulatory activities looked at the application of nanotechnology to sensor technologies. Before joining the FDA in 2007 she did postdoctoral research at the Center for Bio/Molecular Science and Engineering at the U.S. Naval Research Laboratory, where she worked on creating fluorescent-based biosensors using organic fluorophores and nanomaterials.
Dr. Sapsford has co-authored over 50 peer-reviewed publications, many in the area of nanotechnology, 12 book chapters and has 1 patent. She has made a number of invited presentations on the topic of nanotechnology, especially in the area of characterization.
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