Kim Sapsford, FDA


Kim E. Sapsford was born in Dusseldorf, Germany in 1974.  She studied chemistry at the University of East Anglia (UEA, Norwich, UK) and in 2001 received her PhD in analytical chemistry developing optical biosensors.  In 2001 she moved to the Center for Bio/Molecular Science and Engineering at the US Naval Research Laboratory, where she worked (until 2007) on creating fluorescent-based biosensors using the NRL Array Biosensor technology developed by Dr. Frances Ligler.  She moved to the US Food and Drug Administration (FDA) in 2007 to the Office of Science and Engineering Laboratories (OSEL), Division of Biology (DB).  Her work involved assessing biotechnology concerning public health safety in particular future biosensing technologies, which included the application of nanotechnology.  She has co-authored forty six peer-reviewed research publications, eleven book chapters and has one patent. Currently (since 2013) she is a Senior Staff Fellow and Scientific Reviewer at FDA in the Office of In Vitro Diagnostic Devices and Radiological Health (OIR), Division of Microbiology Devices (DMD). 

(Updated Sept. 2014)

Abstract:

 

U.S. Food and Drug Administration

The U.S. Food and Drug Administration (FDA) regulates a wide range of products, including foods, cosmetics, drugs, devices, veterinary products, and tobacco products some of which may utilize nanotechnology or contain nanomaterials.  FDA supports the responsible development of nanotechnology, including products relevant to nanosensors.  FDA will provide guidance on currently available tools, standards, and approaches, as appropriate, to assess the safety, efficacy, quality, and performance of FDA-regulated products that may incorporate nanomaterials or otherwise involve the application of nanotechnology. 

FDA resources specific to nanotechnology can be found at the following website:

http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/default.htm

The agency recently released a FDA wide guidance document “Considering Whether an FDA-Regulated product Involves the Application of Nanotechnology” which represents FDA’s current thinking on this topic:

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM401695.pdf

Depending on the nature of a product, different Centers within FDA would be responsible for its regulation.   Nanosensors for public healthcare applications, for example, would likely to be regulated by the Center for Devices and Radiological Health (CDRH).   However, the FDA Office of Combination Products makes the final determination on which FDA Center has jurisdiction.

FDA has a number of research programs within the agency that look at various aspects of nanotechnology and information about each of these programs can be found at the main FDA nanotechnology website given above.  For example, the agency has two nanotechnology core facilities, one housed at the National Center for Toxicological Research (NCTR) in Arkansas and the other in CDRH’s Office of Science and Engineering Laboratories (OSEL) in Maryland.  Both contain state of the art instrumentation for the characterization of nanomaterials.

Inquiries about nanotechnology at FDA can be directed to Dr. Jed Costanza (email: Jed.Costanza@fda.hhs.gov). Questions concerning CDRH specific products can be directed to Dr. Kevin Lorick (email: Kevin.Lorick@fda.hhs.gov) or Dr. Kim Sapsford (email: Kim.Sapsford@fda.hhs.gov).