The Office of Regulatory Affairs (ORA) is charged with ensuring that FDA-regulated products that contain nanomaterials or otherwise utilize nanotechnology comply with current regulations and statutory requirements. This is typically accomplished by a variety of regulatory mechanisms, including the utilization of three key components: Investigations, Compliance, and the National Laboratory Resource. ORA is providing its scientists with the infrastructure and resources to address the questions raised by nanotechnology, such as effects on manufacture, quality control, and physical characterization of materials.

ORA’s Arkansas Regional Lab (ORA/ARL) and the Winchester Engineering and Analytical Center (ORA/WEAC) are collaborating with other FDA Centers (e.g., NCTR), federal agencies, academic institutions and private industry to enhance ORA’s regulatory science research important for compliance and enforcement determinations in FDA-regulated products. Current ORA nanotechnology regulatory science research focuses primarily on development of screening methodologies for the detection of nanomaterials in FDA-regulated products

For further information:

Office of Regulatory Affairs
Division of Field Science
12420 Parklawn Drive
Rockville, MD 20857
Telephone: 301-796-6600