11-05 :: May/June 2011

nanotimes News in Brief

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FDA Outlines Roadmap for Discussion on Nanotechnology in Regulated Products

The U.S. Food and Drug Administration released draft guidance to provide regulated industries with greater certainty about the use of nanotechnology, which generally involves materials made up of particles that are one billionth of a meter in size. The guidance outlines the agency’s view on whether regulated products contain nanomaterials or involve the application of nanotechnology. The draft guidance, “Con- sidering Whether an FDA-Regulated Product Involves the Application of Nanotechnology,” is available online and open for public comment. It represents the first step toward providing regulatory clarity on the FDA’s approach to nanotechnology. Specifically, the agency named certain characteristics – such as the size of nanomaterials used and the exhibited properties of those materials – that may be considered when attempting to identify applications of nanotechnology in regulated products.

“With this guidance, we are not announcing a regulatory definition of nanotechnology,” said Margaret A. Hamburg, MD, Commissioner of Food and Drugs. “However, as a first step, we want to narrow the dis- cussion to these points and work with industry to determine if this focus is an appropriate starting place.”

For products subject to premarket review, the FDA intends to apply the points contained in the draft guidance, when finalized, to better understand the properties and behavior of engineered nanomaterials. For products not subject to premarket review, the FDA will urge manufacturers to consult with the agency early in the product development process so questions related to the regulatory status, safety, effective- ness or public health impact of these products can be adequately addressed. FDA will develop additional guidance documents related to specific products or product categories in the future, as needed.

It is critical for FDA to understand how changes in physical, chemical or biological properties seen in nanomaterials affect the safety, effectiveness, performance or quality of a product that contains such materials. FDA is releasing its document in coordination with the “Policy Principles for the U.S. Decision- Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials” issued on June 9, 2011, jointly by the Office of Science and Technology Policy, Office of Management and Budget, and the United States Trade Representative.

http://www.fda.gov/RegulatoryInformation/Guidances/ucm257698.htm

http://www.whitehouse.gov/sites/default/files/omb/inforeg/for-agencies/nanotechnology-regulation-and-oversight- principles.pdf