• Does not establish any regulatory definitions. 
• It is intended to help industry and others identify when they should consider potential implications for regulatory status, safety, effectiveness, or public health impact that may arise with the application of nanotechnology in FDA-regulated products. 
• Nor does this guidance document address the regulatory status of products that contain nanomaterial or otherwise involve the application of nanotechnology, which are currently addressed on a case-by-case basis using FDA’s existing review processes. The application of nanotechnology may result in product attributes that differ from those of conventionally-manufactured products, and thus may merit examination. 
• However, FDA does not categorically judge all products containing nanomaterial or otherwise involving application of nanotechnology as intrinsically benign or harmful. 

FDA has not to date established regulatory definitions of “nanotechnology,” “nano scale” or related terms. 

National Nanotechnology Initiative Program defines nanotechnology as “the understanding and control of matter at dimensions between approximately 1 and 100 nanometers, where unique phenomena enable novel applications.”Other factors such as function, shape, charge, the ratio of surface area to volume, or other physical or chemical properties have also been mentioned in various published definitions.    

As a first step toward developing FDA’s framework for considering whether FDA-regulated products include nanomaterial or otherwise involve nanotechnology, the agency has developed the points discussed below:

At this time, when considering whether an FDA-regulated product contains nanomaterial or otherwise involves the application of nanotechnology, FDA will ask: