Draft Guidance from FDA on Regulation of Nanotechnology

Draft guidance issued June 9th by the US Food and Drug Administration lays out possible regulatory requirements including premarket reviews for device manufacturers whose products incorporate nanotechnology.

“The application of nanotechnology may result in product attributes that differ from those of conventionally-manufactured products, and thus may merit examination,” states the guidance document. “However, FDA does not categorically judge all products containing nanomaterials or otherwise involving application of nanotechnology as intrinsically benign or harmful.”

The guidance lists two points of consideration the FDA has proposed to apply broadly to all products it oversees. First, in considering whether an FDA-regulated product contains or utilizes nanotechnology. The agency would inquire whether an engineered material or end product has a minimum of one dimension falling within the range of 1 to 100 nanometers. Second, the agency would ask whether an engineered material or product exhibits physical, chemical or biological characteristics attributed to its dimensions even if those dimensions fall outside the nanoscale range. Such considerations would apply to both new products as well as to existing ones undergoing manufacturing changes.

The FDA concludes that for products incorporating nanotechnology that require premarket reviews, the agency intends to use the points mentioned above as part of the review process to more fully understand how nanomaterials affect product properties and behaviors. In cases where products utilizing nanotechnology do not require premarket reviews, the FDA recommends that manufacturers consult with the regulator early on in their development processes in order to effectively address questions involving regulatory status, safety and effectiveness or public health.

In a press release accompanying the guidance, FDA commissioner Margaret Hamburg emphasized that the new document does not represent a “regulatory definition of nanotechnology,” but is intended to scope out the parameters of any potential regulatory structure targeting this issue.

The FDA is accepting public comments on the guidance for the next two months.

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