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FDA Releases Draft Guidance Toward Nanotech Regulation

Posted: June 15, 2011

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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.

The agency notes that these considerations apply not only to new products, but also may apply when manufacturing changes alter the dimensions, properties, or effects of an FDA-regulated product or any of its components. Additionally, they are subject to change in the future as new information becomes available, and to refinement in future product-specific guidance documents.

The agency adds that is will develop additional guidance documents related to specific products or product categories in the future, as needed. It is critical for the FDA to understand how changes in physical, chemical or biological properties seen in nanomaterials affect the safety, efficacy, performance or quality of a product that contains such materials.