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U.S. Department of Health and Human Services

Science & Research

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2013 FDA Nanotechnology Regulatory Science Research Categories

FDA encourages promotion of, and participation in, regulatory science research and other efforts to increase scientific understanding, to facilitate assessment of data needs for regulated products.  Such activities should, where appropriate, be coordinated with and leveraged against activities supported by other Federal agencies, the private sector, or other international regulatory counterparts.  The following provides examples of areas of regulatory science research interest to FDA:

Physico-Chemical Characterization in FDA-Regulated Products

  • Develop improved methods and tools to detect and measure the physical structure, chemical properties, and safety of nanomaterials in FDA-regulated products:
    • In biological matrices, to assess the impact of biological systems on physical structure, chemical properties, and safety; and
    • To be used by manufacturers to assess product quality and consistency.

Nonclinical Modeling of Nanomaterials in FDA-Regulated Products

  • Develop and evaluate in vitro and in vivo assays and models to assess safety and/or efficacy of nanomaterials in FDA-regulated products, in order to:
    • Better understand the adequacy of preclinical evaluations necessary to assess safety and efficacy of nanomaterials;
    • Obtain data on absorption, distribution, metabolism, and excretion, relevant to in vivo fate of nanomaterials; and
    • Obtain data to improve understanding of structure-function relationships.

Risk Characterization Information

  • Targeted research in FDA-regulated product areas of potential nanotechnology applications where risk characterization information would help to enhance the understanding of hazard identification, exposure science, and risk modeling. 

Risk Assessment

  • Enhance state of knowledge and scientific evidence to support potential development of generalized class-based approaches to risk assessment of FDA-regulated products containing nanomaterials

Risk Communication

  • Improve risk communication associated with FDA regulated product areas that either contain nanomaterials or product areas otherwise relevant to nanotechnology.

The FDA’s Regulatory Science Research Project Categories align with those proposed by the National Nanotechnology Initiative (NNI).  A copy of their report (Draft NNI Strategy for Nanotechnology Related Environmental, Health and Safety Research) can be found on the NNI website.

For more information on FDA nanotechnology research projects, please email us at:  Nanotechnology@fda.hhs.gov.