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US FDA announces "Workshop on Medical Devices and Nanotechnology"
Published: Saturday 21 August 2010
The US Food and Drug Administration (FDA) has published announced a Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and Biocompatibility, to be held on the 23rd September 2010 in Washington D.C..
According to the notice in the 21st August 2010 Federal Register (Vol. 75, No. 162, page 51829), ‘FDA is holding this public workshop to obtain information on a number of specific questions regarding manufacturing and characterization requirements and the biocompatibility evaluation for medical devices utilizing nanotechnology.‘
The FDA is seeking public comments; comments are to be submitted by the 15th September 2010, if they are to be considered for the workshop; all other comments are to be submitted by the 22nd October 2010.
Follow this link to download the full Federal Register notice.
During the 2nd Annual Conference on Nanotechnology Law, Regulation and Policy (organised by the US Food and Drug Law Institute, held in Washington DC on the 18th and 19th February 2009), an a delegation from various offices at the US Food and Drug Administration (FDA) commented on the question whether the FDA was planning to provide guidance to industry, as recommended by a number of stakeholder upon release of the FDA’s Nanotechnology Task Force report in July 2007. (4th March 2009)