http://www.fda.gov/nanotechnology/
The US Food and Drug Administration regulates a wide range of products, including foods, cosmetics, drugs, devices, and veterinary products, some of which may utilize nanotechnology or contain nanomaterials. The FDA defines "nanotechnology" as research and technology or development of products regulated by FDA that involve all of the following:
- 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 nanometers;
- the creation and use of structures, devices and systems that have novel properties and functions because of their small size; and,
- the ability to control or manipulate the product on the atomic scale.
With the advent of nanotechnology, the regulation of many products will involve more than one Center, for example a "drug" delivery "device". In these cases the assignment of regulatory lead is the responsibility of the Office of Combination Products. To facilitate the regulation of nanotechnology products, the Agency has formed a NanoTechnology Interest Group (NTIG), which is made up of representatives from all the Centers. The NTIG meets quarterly to ensure there is effective communication between the Centers. Most of the Centers also have working groups that establish the network between their different components. There are also a wide range of products involving nanotechnologies, which are regulated by other federal agencies. The breadth of products regulated by FDA and the other agencies is shown in below.
There are also a wide range of products involving nanotechnologies which are regulated by other federal agencies. The breadth of products regulated by FDA and the other agencies is shown in below.
For insight on how nanotechnology products are regulated by FDA, please use the link below:
FDA regulation of Nanotechnology Products
For more information about nanotechnology, please use the link below to the National Nanotechnology Initiative web site. This site also contains links to other federal agencies involved in nanotechnology
http://www.nano.gov
This website will direct you to documents in the respective Centers that will help you develop an understanding of how different products are regulated, and how you should proceed to get your product approved for marketing. Please note: While there are no nanotech-specific guidance documents at this time, all existing guidance documents would apply to nanotech products. Some resources on this site require you to have Microsoft Word to view them.
