Guidance for Industry Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology

摘要

This guidance is intended for manufacturers, suppliers, importers and other stakeholders. The guidance describes FDA's current thinking on whether FDA-regulated products2 contain nanomateri.al.sor otherwise involve the application of nanotechnology. FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities...This guidance document does not establish any regulatory definitions. Rather, it is intended to help industry and others identify when they should consider potential implications for regulatory status, safety, effectiveness, or public health impact thatmay arise with the application of nanotechnology in FDA-regulated products. Public input on the guidance may also inform the development of any regulatory definitions in the future, as needed.