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 and "selected participants representing a range of constituencies."
For more information, the notice does provide a contact person:
Contact Person: Daya Ranamukhaarachchi, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5574, Silver
Spring, MD 20993, 301-796-6155, FAX: 301-847-8510, email:
Daya.Ranamukhaarachchi@fda.hhs.gov.
Considering that the workshop begins at 8AM hopefully there will be plenty of coffee.
