Monday’s federal register carried a notice from the Food & Drug Administration (FDA) announcing a public workshop on "Medical Devices & Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations" to be held September 23 2010, from 8AM to 5PM at the Hilton Washington DC/North Gaithersburg, in Gathersburg, MD. Persons interested in participating in the workshop need to register by September 15, 2010. The notice provides a link and details on how to register. If anyone wishes to make an oral presentation during the workshop sessions, that needs to be indicated at the time of registration.
According to the notice
The objective of this public workshop is to obtain information on manufacturing, characterization, and evaluation of biocompatibility of medical devices containing or utilizing nanomaterials and nanostructures.
Issues for Discussion
The workshop will focus on two topics: (1) Manufacturing and characterization of medical devices containing or utilizing nanomaterials or nanostructures; (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.
Registrants for the workshop will be participate in the oral presentations discussed above and via two roundtable discussions between the FDA’s staff …