A general finding of the report is that nanoscale materials present regulatory challenges similar to those posed by products using other emerging technologies. However, these challenges may be magnified both because nanotechnology can be used in, or to make, any FDA-regulated product, and because, at this scale, properties of a material relevant to the safety and (as applicable) effectiveness of FDA-regulated products might change repeatedly as size enters into or varies within the nanoscale range. In addition, the emerging and uncertain nature of the science and potential for rapid development of applications for FDA-regulated products highlights the need for timely development of a transparent, consistent, and predictable regulatory pathway. The report includes a number of recommendations:
+ Consideration of guidance that would clarify what information manufacturers should give FDA about products, and also when the use of nanoscale materials may change the regulatory status of particular products.
+ That manufacturers contact the FDA early in the product development process. In addition, the report recommends that the agency should assess data needs for regulated nanotechnology products, including biological effects and interactions of nano-particles.
+ That FDA develop in-house expertise and ensure the consideration of new information on nanotechnology as it becomes available. FDA also should evaluate current testing approaches to assess the safety, effectiveness, and quality of nanoscale materials.
Anyone find anything new or surprising in most of that?