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Tag Archives: Food and Drug Administration

FDA Science Board to Meet

In a notice published in the Federal Register for 05/04/2011, the FDA Science Board, an advisory panel that provides advice to the FDA Commissioner and the Commission on "specific complex and technical issues as well as, emerging issues within the scientific community, in industry and academia . . . .advice to the Agency on keeping pace with technical and scientific evolutions in the fields of regulatory science, or formulating an appropriate research agendas; upgrading its scientific and research facilities to keep pace with these changes", announced that it be having a meeting on 05/20/2011 at the FDA building in Silver Spring MD. Part of the meeting will consist of the Science Coard receiving updates on the FDA’s Nanotechnology Research Program.

Members of the public who are interested in presenting data, information or their views on the FDA’s Nanotech Research Program are invited to submitt written material to

Ms. Martha Monser

Office of the Commissioner, FDA

10903 New Hampshire Ave.

Bldg 32 Rm 4286

Silver Spring, MD 20993-0002

by 05/13/2011. Anyone interested in making an oral presentation at the meeting should submit, again to Ms. Monser at the address above, names and contact information for participants, along with an estimate of how long the presentation might run. Due to the limits of time for presentations, and to give everyone a fair chance, the FDA may hold a lottery.

Meeting materials will be posted to the FDA’s website by 05/18/2011. For those unable to attend in person the meeting will be webcast.…

FDA Public Workshop on Medical Devices & Nanotechnology

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 …