The US Food and Drug Administration (FDA) issued a draft guidance to give direction to regulated industries with a higher level of certainty on the use of nanotechnology, which involves materials that measure only around one billionth of a meter.
The draft guidance presents the agency's point of view whether nanomaterials are present in regulated products or the products are manufactured using nanotechnology.
The guidance, "Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology," has been published online and is open to commenting by the general public. It offers regulatory clarity on FDA’s position regarding the use of nanotechnology. The agency cited certain characteristics that may be evaluated to determine the use of nanotechnology in regulated products such as the size and properties of the nanomaterials used. For products that require pre-market review, the FDA plans to use the details present in the draft guidance, to get clarity on the behavior and characteristics of engineered nanomaterials.
The FDA will insist that manufacturers must check with the agency during the initial stages of the product development to address queries related to the safety, effectiveness, regulatory status, or impact on public health of products that are not subject to pre-market review. The guidance helps FDA to comprehend how variations in chemical, physical, or biological properties in nanomaterials influence the product’s effectiveness, safety, quality or performance containing such materials.
FDA is launching the document with the "Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials" on June 9, 2011. This document is released by the Office of Science and Technology Policy in collaboration with the United States Trade Representative, and Office of Management and Budget.