Draft Guidance: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology

The agency is issuing a draft guidance on considering whether an FDA-regulated product contains nanomaterials or otherwise involves the use of nanotechnology.  FDA’s issuance of this guidance is a first step toward providing regulatory clarity on FDA’s approach to nanotechnology.  Over time, the agency plans to issue more specific guidances tailored to particular products or classes of products.  These actions are consistent with the 2007 FDA Nanotechnology Task Force’s science and policy recommendations to the Commissioner.