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®: CRE Regulatory Action of the Week

FDA Holding Public Workshop on Nanotechnology and Medical Devices
The U.S. Food and Drug Administration is holding a public workshop entitled "Medical Devices & Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations.'' The purpose of this workshop is to obtain information on manufacturing, characterization, and biocompatibility evaluation of medical devices containing or utilizing nanomaterials and nanostructures, including diagnostics. FDA is seeking input on these topics and requests comments on a number of related questions.

The workshop will be held on September 23, 2010, 8 a.m. to 5 p.m. Anyone interested in attending must register by 5 p.m. on September 15, 2010. Space availability permitting, on-site registration will be available on a first come first serve basis. In order to be considered for workshop discussion, comments must be submitted by September 15, 2010. All other comments must be submitted by October 22, 2010.

The public workshop will be held at the Hilton Washington DC/North Gaithersburg, 620 Perry Pkwy, Gaithersburg, MD 20877.

The workshop will focus on two topics: (1) Manufacturing and characterization of medical devices containing or utilizing nanomaterials or nanostructures; and (2) biocompatibility evaluation of medical devices containing or utilizing nanomaterials or nanostructures. The discussion on manufacturing and characterization will include the evaluation of physico-chemical properties of nanomaterials or nanostructures, characterization methods required, device manufacturing processes and evaluation of the final processed device after sterilization, and stability and aging studies. The discussion on biocompatibility evaluation will include testing for potential release of nanomaterials and additional testing considerations other than standard testing methods to determine the biocompatibility and toxicity of devices containing or utilizing nanomaterials or structures.

The meeting registration Web page is located here.