The United States Food and Drug Administration (FDA) late last week released draft guidance designed to provide regulated industries with greater certainty about the use of nanotechnology, by providing such industries with the agency’s views on whether regulated products contain nanomaterials or involve the application of nanotechnology. The draft guidance, “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology,” represents the first step toward providing regulatory clarity on the FDA’s approach to nanotechnology. According to Margaret A. Hamburg, MD, Commissioner of Food and Drugs, “With this guidance, we are not announcing a regulatory definition of nanotechnology. However, as a first step, we want to narrow the discussion to these points and work with industry to determine if this focus is an appropriate starting place.” The agency named certain characteristics – such as size of the nanomaterials used and the exhibited properties of those materials – that may be considered by the agency when attempting to identify applications of nanotechnology in regulated products. The draft document is available online and open to public comment.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm258377.htm