About FDA

Laboratory of Emerging Biosensors and Biotechnology

Laboratory Leader: Kim Sapsford-Medintz 301-796-0311 kim.sapsford@fda.hhs.gov

Biosensors and Biotechnology encompass a wide range of FDA regulated products such as diagnostic devices, nanotechnology, implantable devices and therapeutic devices.  The role of the laboratory of Emerging Biosensors and Biotechnology is to support the scientific basis for the FDA’s regulatory decision-making throughout the total product life cycle by developing independent laboratory information to answer immediate regulatory questions and to aid in regulatory decision-making. In addition the laboratory includes as its mission the opportunity to explore new emerging technologies as potential areas of research in anticipatory investigations for future regulatory needs.

The scope of this laboratory concerns three main focus areas: (1) Emerging biosensors and lab-on-a-chip platforms for point-of-care diagnostics/personalized medicine, (2) nanoparticle characterization and application to diagnostic devices, and (3) radiation safety and novel radiation-based therapeutic agents.  Staff in the Laboratory of Emerging Biosensors and Biotechnology assess many facets of these new and emerging technologies by studying how device design and device components can effect performance and hence safety and effectiveness.  The laboratory staff actively collaborate both within FDA, with other government agencies and academia and the research has resulted in scientific reviews of medical devices, peer reviewed manuscripts, invited presentations and seminars, consensus standards development and the development of guidance documents to assist reviewers and industry.

Page Last Updated: 11/03/2014
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