Biomedical Engineering Reference
In-Depth Information
As might be expected, the agency has developed its own definition of nanomaterial, which is
contained in a Guidance issued in 2011.
*
In that document, the Agency highlighted the following:
1.
Engineered material or end product
This term is used to distinguish between products that have been engineered to contain
nanoscale materials or involve the application of nanotechnology from those products that
contain incidental or background levels of nanomaterials or those that contain materials
that naturally occur in the nanoscale range. The FDA is particularly interested in the
delib-
erate
manipulation and control of particle size to produce specific properties, because the
emergence of these new properties or phenomena may warrant further evaluation. (empha-
sis added)
2.
At least one dimension in the nanoscale range (~1-100 nm)
A size range of approximately 1-100 nm is commonly used in various working defini-
tions or descriptions proposed by the regulatory and scientific community. In this size
range, materials can exhibit new or altered physicochemical properties that enable novel
applications. Accordingly, a range of approximately 1-100 nm should be applied as a first
reference point in considering whether an FDA-regulated product contains nanomaterials
or otherwise involves application of nanotechnology.
3.
Exhibits properties or phenomena … that are attributable to its dimension(s)
These terms are used because properties and phenomena of materials at the nanoscale
enable applications that can affect safety, effectiveness, performance, quality and, where
applicable, public health impact of FDA-regulated products. For example, dimension-
dependent properties or phenomena may be used for functional effects such as increased
bioavailability, decreased dosage, or increased potency of a drug product, decreased
toxicity of a drug product better detection of pathogens, enhanced protection offered by
improved food packaging materials, or improved delivery of a functional ingredient or a
nutrient in food. The properties and phenomena may be due to altered chemical, biological,
or magnetic properties, altered electrical or optical activity, increased structural integrity,
or other unique characteristics of nanoscale materials not normally observed in their larger
counterparts (emphasis added). These changes may raise questions about the safety, effec-
tiveness, performance, quality, or public health impact of the products. In addition, con-
siderations such as routes of exposure, dosage, and behavior in various biological systems
(including specific tissues and organs) are critical for evaluating the wide array of products
under the FDA's jurisdiction.
†
(emphasis added)
In a Questions and Answers document accompanying the 2011 Guidance, the Agency stated how
the Guidance should be applied:
For products subject to premarket notice or review, FDA intends to incorporate attention to nanomate-
rials into its product-specific review procedures and apply certain considerations to better understand
the properties and behavior of engineered nanomaterials. For products not subject to premarket review,
manufacturers are encouraged to consult with FDA to reduce the risk of unintended harm to human or
animal health. [NOTE: No product sold in the United States requires a premarket submission simply
because it contains nanomaterials, and the incorporation of nanomaterials would be one element to
cover in a submission otherwise required for a product.]
Industry is encouraged to consult with the agency early in the product development process to address
questions related to the regulatory status, safety, effectiveness, or public health impact of products that
*
U.S. Food and Drug Administration. 2011. Draft guidance for industry: Considering whether an FDA-regulated prod-
uct involves the application of nanotechnology. http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/
ucm257926.htm.
†
Id.
(citations omitted).
