FDA update – June 10, 2011

Draft Guidance for Industry: Considering Whether an FDA Regulated Product Involves the Application of Nanotechnology

This guidance document

  • 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:

  1. Whether an engineered material or end product has at least one dimension in the Nano scale range (approximately 1 nm to 100 nm); or
  2. Whether an engineered material or end product exhibits properties or phenomena, including physical or chemical properties or biological effects, that are attributable to its dimension, even if these dimensions fall outside the Nano scale range, up to one micrometer.  


There is a critical need to learn more about the potential role and importance of dimensions in the characteristics exhibited by engineered nanomaterial that may be used in producing products regulated by FDA.  Premarket review, when required, offers an opportunity to better understand the properties and behavior of products that contain engineered nanomaterial or otherwise involve application of nanotechnology.  And where products applying nanotechnology are not subject to premarket review, the agency urges manufacturers to consult with the agency early in the product development process.  In this way, any questions related to the regulatory status, safety, effectiveness, or public health impact of these products can be appropriately and adequately addressed.  

For more information on this guidance you can go to the following link: http://www.fda.gov/RegulatoryInformation/Guidances/ucm257698.htm or contact mdi at info@mdiconsultants.com REF: Guidance Nanotechnology.