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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 …

The NNI Strategic Planning Stakeholder Workshop

In a notice in today’s Federal Register the National Nanotechnology Coordination Office announced that it will be holding a public workshop on July 13-14, 2010, for the purpose of giving stakeholders (defined as representatives of the research community, the private sector and NGOs and members of the general public) a forum for presenting their input regarding updating the US National Nanotechnology Initiative Strategic Plan, last updated in 2007. Specifically, the Federal agencies that take part in the NNI are seeking input on the objectives of the strategic plan and on the approaches to achieving those objectives.

Pre-registration is required, since it’s on a "first come, first served" basis. Those planning to attend the workshop, to be held at the Hotel Palomar in Arlington Virginia, may register online at http://www.nano.gov/html/meetings/strategicplan/register.html, via e-mail at strategy@nnco.nano.gov or via regular snail mail at Strategic Planning Workshop, c/o NNCO, 4201 Wilson Blvd., Stafford II, Suite 405, Arlington, VA 22230. Registrations must be received by 4PM July 7, 2010.…

National Nanotechnology Coordination Office Announces a Public Meeting

Today’s Federal Register carries a notice of a public meeting on Tuesday March 30th and Wednesday March 31st 2010 to be held at the Holiday Inn Rosslyn-Key Bridge in Arlington Virginia .

The meeting will be a workshop designed "to provide an open forum to discuss the state-of-the-art of the science related to environmental, health, and safety aspects of nanomaterials in two areas: Risk Management Methods and Ethical, Legal, and Societal Implications (ELSI) of Nanotechnology."

Registration is required to attend the workshop and information on how to register is available in the notice. Anyone wishing to present 3-5 minutes of public comments also needs to register. Written or electronic comments must be submitted via e-mail at capstone@nnco.nano.gov until April 30, 2010. Written comments can also be mailed to Capstone Workshop, c/o NNCO, 4201 Wilson Blvd., Stafford II, Suite 405, Arlington, VA 22230.  

Those unable to attend the workshop in person can view the main sessions via webcast. The draft agenda for the workshop is below. Among the invited speakers and guest is John Monica, a partner in Porter Wright’s DC office. Further information about the workshop is available on the National Nanotechnology Initiative website.

Schedule and Agenda

Draft Agenda (2/25/10):

Tuesday, March 30

7:30 a.m. Registration and Continental Breakfast

8:30 a.m. Morning Introductory Session: -Welcome

-Opening Remarks

– Highlights from previous workshops

– Introduction to Risk Management Methods: Gary Marchant, Arizona State University Greg Lowry, Carnegie Mellon University

– Introduction to Ethical, Legal, and Societal Implications of Nanotechnology …

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