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
- FDA Nano CORES (Collaborative Opportunities for Research Excellence in Science)
- FDA Office of Women's Health
- National Science Foundation (NSF) FDA Scholar In Residence CDRH-CDER Collaboration on Characterization of Complex Drug Products Containing Nanomaterials
Characterization of Complex Drug Products Containing Nanomaterials
Transmission Electron Micrographs of silver nanoparticles at different magnifications.
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.
Ryan Boehm, Ph.D.
Wenchun Feng, Ph.D.
Bonhye Koo, Ph.D.
Soumyarwit Manna, Ph.D.
Teresa Palacios-Hernandez, Ph.D.
Paul Turner, Ph.D.
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
University of North Carolina-Chapel Hill
NC State University
Argonne National Laboratory
National Characterization Laboratory/National Cancer Institute
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
TEM Grid Glow Discharger
Turbo Pumped Sputter Coater
TEM Grid Plunger Freezer
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
- CDRH Draft Guidance - Medical Devices Incorporating Nanotechnology
- FDA - Guidance for Industry Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology
- Nanotechnology guidance: ISO/PDTS 10993-21 Biological evaluation of medical devices-Part 22: Guidance on nanomaterials
Standards Committees and Consortia
- ASTM International Committee on Nanotechnology (E56.02)
- ISO TC229, WG3 - Nanotechnology
- ISO TC194, WG17 - ISO 10993, Part 22 - Nanotechnology
- ILSI/Health Effects Science Institute - Genetic Toxicology Technical Committee (GTTC) on Nanomaterials.
Selected peer-review publications
- Elespuru RK et al. Genotoxicity assessment of nanomaterials: Recommendations on best practices, assays, and methods. Toxicol. Sci. 2018. doi.org/10.1093/toxsci/kfy100.
- Skoog SA, et al. Biological responses to immobilized microscale and nanoscale surface topographies. Invited Review. Pharmacology and Therapeutics 182:33-55, 2018. (doi: 10.1016/j.pharmthera.2017.07.009, June 2017). Impact Factor = 11.1.
- Yang KH, et al. Ultrananocrystalline diamond-coated nanoporous membranes support SK-N-SH neuroblastoma endothelial cell attachment. Interface Focus. 2018 Jun 6;8(3):20170063. doi: 10.1098/rsfs.2017.0063.
- Savery LC, et al. Deriving a provisional tolerable intake for intravenous exposure to silver nanoparticles released from medical devices. Regul Toxicol Pharmacol. 85:108-118, 2017. doi: 10.1016/j.yrtph.2017.01.007.
- Petrochenko PE, et al. Pulse laser deposited nanosilver-PMMA composite coating optimized to provide robust antimicrobial efficacy while minimizing human bone stem cell toxicity. Toxicol In Vitro 44:248-255, 2017.
- Skoog SA, et al. Effects of nanotopography on the in vitro hemocompatibility evaluation of nanocrystalline diamond coatings. J Biomed Materials Res: Part A 105(1):253-264, 2017. doi: 10.1002/jbm.a.35872.
- Riaz Ahmed KB, et al. Silver nanoparticles: significance of physicochemical properties and assay interference on the interpretation of in vitro cytotoxicity studies. Toxicol In Vitro 38:179-192, 2017. DOI: 10.1016/j.tiv.2016.10.012.
- Zhang Q, et al. Effects of iron oxide nanoparticles on biological responses and MR imaging properties in human mammary healthy and breast cancer epithelial cells. J Biomed Materials Res: Part B - Appl Biomaterials 104(5):1032-1042, 2016. doi: 10.1002/jbm.b.33450.
- Austin CA, et al. Distribution and accumulation of 10 nm silver nanoparticles in maternal tissues and visceral yolk sac of pregnant mice, and a potential effect on embryo growth. Nanotoxicology 10:654-661, 2016. dx.doi.org/10.3109/17435390.2015.1107143
- Mishra A, et al. Silver nanoparticle-induced autophagic-lysosomal disruption and NLRP3-inflammasome activation in HepG2 cells is size-dependent. Toxicol Sciences 150(2):473-487, 2016. doi: 10.1093/toxsci/kfw011.