Nanotechnology: A Report of the U.S. Food and Drug Administration Nanotechnology Task Force

Publication Date : 2007
56 Visited Entry Date : 2013/04/15

International

English
Document type Report
Subject Regulatory & Legal Aspect
Summary
As other emerging technologies have in the past, nanotechnology poses questions regarding the adequacy and application of regulatory authorities. The then Acting Commissioner of the Food and Drug Administration (FDA) initiated the Nanotechnology Task Force (Task Force) in 2006 to help assess these questions with respect to FDA's regulatory authorities, in light of the current state of the science for nanotechnology. This report offers the Task Force's initial findings and recommendations to the Commissioner.
The report includes:
- A synopsis of the state of the science for biological interactions of nanoscale materials;
- Analysis and recommendations for science issues; and
- Analysis and recommendations for regulatory policy issues.
The report addresses scientific issues as distinct from regulatory policy issues in recognition of the important role of the science in developing regulatory policies in this area, rapid growth of the field of nanotechnology, and the evolving state of scientific knowledge relating to this field.
The report also addresses the need to evaluate whether the tools available to describe and evaluate nanoscale materials are sufficient, and the development of additional tools where necessary.
Content
Executive Summary

Introduction
Task Force Mission     
Definitions for Nanotechnology and Related Terms     
Organization of this Report     

State of the Science of Nanotechnology Relevant to FDA

Science Issues
Introduction     
Issue: Understanding Interactions of Nanoscale Materials with Biological Systems     
Issue: Adequacy of Testing Approaches for Assessing Safety and Quality of Products Containing Nanoscale Materials     

Regulatory Policy Issues
Background     
Discussion     
Issue: Ability of FDA to Identify FDA-Regulated Products that Contain Nanoscale Materials     
Issue: Scope of FDA's Authority Regarding Evaluation of Safety and Effectiveness     
Issue: Permissible and Mandatory Labeling     
Issue: National Environmental Policy Act     
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