FDA Seeks Information on Safety and Effectiveness of Nanodevices

By Ricardo Carvajal –

FDA announced a public workshop intended to help the agency gather information on the safety and effectiveness of medical devices that use nanotechnology.  FDA posted questions on its website that focus on manufacturing, characterization, and biocompatibility issues of the sort that might arise during the agency’s review of such devices.

The workshop announcement follows on the heels of the FDA Nanotechnology Task Force’s presentation to the FDA Science Board (available here), which outlined FDA’s plan to develop its nanotechnology regulatory science program.  Earlier this year, Commissioner Hamburg acknowledged the need to bulk up the agency’s regulatory science capabilities generally, and specifically highlighted the agency’s plan to build its scientific capacity in nanotechnology in testimony before Congress.  These developments suggest that the agency is earnestly pursuing efforts to get up to speed on nanotech.