The US Food and Drug Administration (FDA) has finalized a 2011 guidance document outlining its regulatory approach for nanotechnology products, including medical products.
As explained by FDA in the guidance, nanotechnology products—sometimes called nanomedicine—are used in a "broad array" of regulated products, such as pharmaceuticals, biologics, medical devices and dietary supplements.
While the guidance loosely defines nanotechnology products as any material between one nanometer (nm) and 100 nm in size, the agency notes that other materials may also be considered nanotechnology products for regulatory purposes, such as if they exhibit similar "properties or phenomena" to other nanotechnology products. These products can be as large as 1,000 nm, FDA says in the guidance.
FDA said those properties and phenomena are often so different than conventionally-manufactured products that they "merit particular examination," though that examination would not begin under the presumption that a product is "intrinsically benign or harmful."
"Based on our current scientific and technical understanding of nanomaterials and their characteristics, FDA believes that evaluations of safety, effectiveness, public health impact, or regulatory status of nanotechnology products should consider any unique properties and behaviors that the application of nanotechnology may impart," FDA writes in its guidance, Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology.
Those "unique properties" present a basic regulatory problem, FDA noted: It's difficult to apply a basic framework to evaluation when each nanotechnology product may be intended to have a different effect, or act differently upon the body.
Instead, FDA said its guidance is intended to offer a basic "initial screening tool that can be broadly applied to all FDA-regulated products" and later refined as FDA's understanding of nanotechnology products becomes more complete.
Points to Consider
FDA's document goes on to list several "points to consider" intended to guide sponsors of nanotechnology products toward a successful regulatory filing.
Outside of the basics—is the product 1-100 nm, or does it exhibit similar properties to a nanotechnology product—sponsors are also asked to consider if a product has been engineered to nano scale, or if it is naturally that way.
"FDA is particularly interested in the deliberate and purposeful manipulation and control of dimensions to produce specific properties, because the emergence of these new properties or phenomena may raise questions about the safety, effectiveness, performance, quality or public health impact that may warrant further evaluation," regulators wrote.
The guidance also notes that FDA will consider both nanotechnology products by themselves and their use as additives or intermediates in other, non-nano products such as food additives.
Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology