Abstract
The Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA) regulates nano-based medical products and therefore is required to address the safety and biological effects of nano-scale materials used in these products. Both in vitro and in vivo toxicological research studies are being conducted at the FDA to help determine the risks versus benefits of these new products. This article will briefly summarize some of the initial research findings from FDA-CDRH studies using TiO2, polystyrene, and silicon nanoparticles.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
Abbreviations
- FDA:
-
US Food and Drug Administration
- CDRH:
-
Center for Devices and Radiological Health
- CDER:
-
Center for Drug Evaluation and Research
- NIST:
-
National Institute of Standards and Technology
References
T.J. Brunner, P. Wick, P. Manser, P. Spohn, R.N. Grass, L.K. Limbach et al., Environ. Sci. Technol. 40, 4374 (2006). doi:10.1021/es052069i
M.S. Chapekar, T.G. Zaremba, R.K. Kuester, V.M. Hitchins, J. Biomed. Mater. Res. 31, 251 (1996). doi:10.1002/(SICI)1097-4636(199606)31:2<251::AID-JBM12>3.0.CO;2-O
J. Choi, Q. Zhang, V.M. Hitchins, N.S. Wang, V. Reipa, Proc. SPIE 6645, 66451Q (2007). doi:10.1117/12.734222
J. Choi, Q. Zhang, V. Reipa, N.S. Wang, M.E. Stratmeyer, V.M. Hitchins, et al., J. Appl. Toxicol. (2008). doi:10.1002/jat1382
C. Frick, A.C. Dietz, K. Merritt, T.H. Umbreit, V.J. Tomazic-Jezic, J. Long Term Eff. Med. Implants 16, 423 (2006)
P.L. Goering, R.K. Kuester, A.R. Neale, M.S. Chapekar, T.G. Zaremba, E.A. Gordon et al., In vitro. Mol. Toxicol. 13, 125 (2000). doi:10.1089/109793300440712
N. Lewinski, V. Colvin, R. Drezek, Small 4, 26 (2007). doi:10.1002/smll.200700595
L.K. Limbach, P. Wick, P. Manser, R.N. Grass, A. Bruinink, W.J. Stark, Environ. Sci. Technol. 41, 4158 (2007). doi:10.1021/es062629t
T.C. Long, J. Tajuba, P. Sama, N. Saleh, C. Swartz, J. Parker et al., Environ. Health Perspect. 115, 1631 (2007)
R.C. Murdock, L. Braydich-Stolle, A.M. Schrand, J.J. Schlager, S.M. Hussain, Toxicol. Sci. 101, 239 (2008). doi:10.1093/toxsci/kfm240
Y. Pan, S. Neuss, A. Leifert, M. Fischler, F. Wen, U. Simon, G. Schmid, W. Brandau, W. Jahnen-Dechent, Small 3, 1941 (2007). doi:10.1002/smll.200700378
J.E. Skebo, C.M. Grabinski, A.M. Schrand, J.J. Schlager, S.M. Hussain, Int. J. Toxicol. 26, 135 (2007). doi:10.1080/10915810701226248
M.R. Taylor, Project on Emerging Nanotechnologies, Woodrow Wilson International Center Report 2006 (Woodrow Wilson International Center for Scholars, Washington, D.C., 2006), p. 1
V.J. Tomazic-Jezic, K. Merritt, T.H. Umbreit, J. Biomed. Mater. Res. 55, 523 (2001). doi:10.1002/1097-4636(20010615)55:4<523::AID-JBM1045>3.0.CO;2-G
V.J. Tomazic-Jezic, T.H. Umbreit, M.E. Stratmeyer, Toxicologist 95(1), abstr 1560 (2006)
U.S. Food and Drug Administration, Nanotechnology—a report of the U.S. Food and Drug Administration Nanotechnology Task Force. July 2007. http://www/fda.gov/nanotechnology/taskforce/report2007.html
H. Valhov, J. Qin, S.M. Johansson, N. Ahlborg, M.A. Muhammed, A. Scheynius et al., Nano Lett. 6, 1682 (2006). doi:10.1021/nl060860z
W.J. Waldman, R. Kristovich, D.A. Knight, P.K. Dutta, Chem. Res. Toxicol. 20, 1149 (2007). doi:10.1021/tx700008n
D.B. Warheit, Toxicol. Sci. 101, 183 (2008). doi:10.1093/toxsci/kfm279
Acknowledgements
We would like to thank Jonghoon Choi (CDRH, FDA), Qin Zhang (CDRH, FDA), Terry Miller (CDER, FDA), James Weaver (CDER, FDA), Nam Sun Wang (University of Maryland), and Vytas Reipa (National Institutes of Standards and Technology) for participation in the in vivo and in vitro studies, Edward A. Gordon (CDRH, FDA) for help with graphics, FDA for funding ORISE fellows (Choi and Zhang), and Gail L. Matson for editorial preparation of the manuscript.
Funding source
Center for Devices and Radiological Health, Food and Drug Administration
Conflict-of-interest disclosure
None.
Author information
Authors and Affiliations
Corresponding author
Additional information
This article is a summary of a presentation by M.E.S. at the IRT meeting for Nanotechnology Solutions for Long-Term Implantable Devices, sponsored by the Telemedicine and Advanced Technology Research Center (TATRC); Houston, Texas; October 23–25, 2007. The opinions expressed are not to be construed as official policy of the US Food and Drug Administration.
Rights and permissions
About this article
Cite this article
Stratmeyer, M.E., Goering, P.L., Hitchins, V.M. et al. What we know and don’t know about the bioeffects of nanoparticles: developing experimental approaches for safety assessment. Biomed Microdevices 12, 569–573 (2010). https://doi.org/10.1007/s10544-008-9261-9
Published:
Issue Date:
DOI: https://doi.org/10.1007/s10544-008-9261-9