FDA Issues Draft Guidance on Nanotechnology

Date: Jun 10, 2011

On June 9, FDA issued a Draft Guidance regarding nanotechnology--Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology. Comments will be accepted on this draft guidance for approximately two months. FDA has also issued a Press Release, FDA takes first step toward greater regulatory certainty around nanotechnology and a Q&A document regarding this matter.

The draft guidance describes points that FDA will consider when determining whether FDA-regulated products contain nanomaterials or otherwise involve the application of nanotechnology. The two points that FDA identifies are:

1) Whether an engineered material or end product has at least one dimension in the nanoscale 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(s), even if these dimensions fall outside the nanoscale range, up to one micrometer.

FDA clarified that this is not a regulatory definition of nanotechnology but rather guidance to assist industry in resolving the fundamental question of whether an FDA-regulated product does in fact involve nanotechnology. FDA will use these points when reviewing products subject to premarket review and encourages manufacturers to apply these points when assessing whether products not subject to premarket review involve nanotechnology. FDA urges manufacturers of nanotech products not subject to premarket review to confer with FDA early in the product development process so that the Agency can help resolve questions relating to regulatory status, safety, effectiveness or public health impact. FDA stresses that nanotech products will be assessed on a product-by-product basis since acceptable levels of uncertainty and risk may vary among product-classes.

FDA's draft guidance was issued concurrent with a policy document issued by the Office of Science and Technology Policy, the Office of Management and Budget and the U.S. Trade Representative (USTR) regarding nanotechnology--Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials.