Nanotechnology is an emerging technology that has the potential to be used in a broad array of FDA-regulated products, including medical products, foods and cosmetics.
Nanomaterials, developed using nanotechnology, are measured in nanometers, — equal to about one-billionth of a meter — so small that they can’t be seen with a regular microscope. These nanomaterials can have different chemical, physical, or biological properties than their conventionally-scaled counterpart materials used in many products regulated by FDA.
- Guidance Fact Sheet: Nanotechnology
- Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes
- Draft Guidance for Industry: Safety of Nanomaterials
- FDA Consumer Update: FDA Continues Dialogue on ‘Nano’ Regulation
Contact PDG to find out how we can help your company with a, 510K, 505(b)(2), or safely implement nanotechnology into your FDA-regulated products and production processes.