US FDA to Hold Nanotechnology Meeting

US FDA will hold a public meeting to gather information related to the implementation of recommendations of the Nanotechnology Task Force Report. The event is scheduled for 8 September in Rockville, MD, USA. There will be several breakout sessions during the day, one of which will focus on medical devices and diagnostic products. Questions that will be addressed include:

 1. Are there general parameters or screening tools by which to evaluate the likelihood that a particular material might have nanoscale-specific properties and to decide when and what sort of further evaluation might be warranted? Are there characteristics and properties of materials that FDA can use to broadly categorize materials with respect to their likelihood of having nanoscale-specific properties warranting further review?

2. What data and information should be considered in determining whether the presence of a nanoscale version of material in an existing device could affect the device’s regulatory status, for example, in determining whether that device remains substantially equivalent to a predicate device?

3. Do the existing Quality System Regulation requirements for process validation adequately address issues for manufacturing nanotechnology products, including issues related to demonstrating batch-to-batch reproducibility?

4. Do you believe that nanoscale products or products that contain nanoscale materials raise any novel questions relevant to their classification as biological products, devices, drugs, or combination products?

For  meeting materials or any additional information,  contact nanotech@fda.hhs.gov or phone +1 301 827 3360.

Tags: Nanotechnology and Microtechnology, US Regulatory