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  1. Science and Research (Medical Devices)

Nanotechnology/Nanotoxicology

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Summary

In the field of nanomedicine, nanoparticles and other nanomaterials are used to create new or improved drugs and medical devices. Medical diagnostics and implantable devices such as orthopedic and dental implants, wound dressings, stents, and catheters represent a large and critical market in the health care industry.

The goal of this research team is to establish a regulatory science foundation to support FDA’s regulatory and guidance roles in nanotechnology and its impact on the human body. The research goals are to develop and advance the methods, tools, and approaches that will improve and enhance the evaluations of the physico-chemical characterization, safety, and efficacy of engineered nanomaterials and nanosurfaces incorporated into medical devices. Nanotechnology is a cross-cutting technology with products evaluated in several regulatory offices within the Center for Devices and Radiological Health (CDRH). We develop non-clinical in vitro, in vivo and in silico tools and models using a multi-disciplinary (cell biology, toxicology, biomedical engineering, analytical chemistry) approach to more readily assess and improve upon the prediction of the safety and efficacy of FDA regulated products incorporating such technology. Projects are focused on four broad areas of investigation: 1) medical devices containing discrete nanoparticles, such as nanosilver, 2) medical devices with immobilized surface nanostructures and topographies for orthopedic and dental implant applications, 3) genotoxicity assessment of nanomaterials using standard and alternative methods, and 4) developing provisional tolerable intake values for nanomaterials using toxicological risk assessment approaches.

Current funding sources

Characterization of Complex Drug Products Containing Nanomaterials

Silver nanoparticles at different magnifications

Transmission Electron Micrographs of silver nanoparticles at different magnifications.

Personnel

FDA Staff:
Benita Dair , Ph.D.
Rosalie Elespuru, Ph.D.
Peter Goering, Ph.D.
Alan Hood, Ph.D.
Shelby Skoog , Ph.D.
Eric Sussman, Ph.D.
Jiwen Zheng, Ph.D.

Research Fellows:
Ryan Boehm, Ph.D.
Lynn Chen
Wenchun Feng, Ph.D.
Bonhye Koo, Ph.D.
Soumyarwit Manna, Ph.D.
Alexander Nguyen
Teresa Palacios-Hernandez, Ph.D.
Paul Turner, Ph.D.
 

FDA collaborators

Silvia De Paoli, Ph.D., CBER
Yamei Gao, Ph.D., CBER
Indira Hewlett, Ph.D., CBER
Jan Simak, Ph.D., CBER
Stephanie Choi, Ph.D., CDER
Darby Kozak, Ph.D., CDER
Katherine Tyner, Ph.D., CDER
Xiaoming Xu, Ph.D., CDER
Qijin Lu, Ph.D., CDRH
Richard Malinauskas, Ph.D., CDRH
Sadia Khan, Ph.D., CFSAN
MaryAnn Principato, Ph.D., CFSAN
Junjie Yin, Ph.D., CFSAN
Anil Patri, Ph.D., NCTR
 

External collaborators

University of North Carolina-Chapel Hill 
NC State University
Argonne National Laboratory
National Characterization Laboratory/National Cancer Institute

Resource facilities

FDA Advanced Characterization Facility (ACF)
Transmission Electron Microscopy (TEM)
Scanning Electron Microscopy (SEM)
Atomic Force Microscopy (AFM)
Inductive Coupled Plasma Mass Spectrometry (ICP-MS)
Laser Ablation system
Ion Chromatography
TEM Grid Glow Discharger
Turbo Pumped Sputter Coater
TEM Grid Plunger Freezer
Ultramicrotome
Microwave tissue embedding processor
Microwave digestion system
Dynamic Light Scattering and Zeta Analyzer
Nanosight Particle Analyzer
qNano Tunable Resistive Pulse Sensing Particle Analyzer

Relevant standards & guidances

Guidances

Standards

Standards Committees and Consortia

Selected peer-review publications