Fda Definition Of Nanotechnology

As described on the NNI website (http://www.nano.gov/index.html), "Nanotechnology is the understanding and control of matter at dimensions of roughly 1-100 nm, where unique phenomena enable novel applications. Encompassing nanoscale science, engineering and technology, nanotechnology involves imaging, measuring, modeling, and manipulating matter at this length scale." Similarly, in a recent publication by the European Science Foundation on Nanomedicine,92 nanotechnology is defined as the following: "In case of these devices, nanoscale objects were defined as molecules or devices within the size range of one to hundreds of nanometers that are the active component or object, even within the frame-work of a larger micro-size device or at a macrointerface." A discussion regarding the definition of nanotechnology is currently an active topic among various organizations. However, while a definition is always useful, the FDA has traditionally dealt with products on a case-by-case basis. This approach is likely to continue for nanotechnology products, regardless of the definition. However, we are actively involved in the various organizations and committees dealing with issues regarding terminology, such as the American Society for Testing and Materials (ASTM) International.

The definition of nanotechnology at the FDA has been consistent with the definition of nano-technology as reported by the NNI. As such, the FDA currently defines nanotechnology with the following definition:

1. The existence of materials or products at the atomic, molecular, or macromolecular levels, where at least one dimension that affects the functional behavior of the drug/device product is in the length scale range of approximately 1-100 nm.

2. The creation and use of structures, devices, and systems that have novel properties and functions because of their small size.

3. The ability to control or manipulate the product on the atomic scale.

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