ASTM Workshop to focus on neurotoxicity testing strategy.
Press Release Summary:
Sponsored by ASTM International Committee F04 and FDA, Determining the Need for and Developing a Strategy for a Neurotoxicity Testing Battery will be held Tuesday, May 19, 2009, in Vancouver. It will address appropriate types and amount of neurotoxicity testing needed to evaluate materials used in medical devices in contact with neural tissue or cerebral spinal fluid. Short presentations will be followed by extended discussion on various topics. Online registration closes May 13.
Original Press Release:
ASTM International Workshop on a Strategy for a Neurotoxicity Testing Battery
W. CONSHOHOCKEN, Pa., 26 February 2009 - A workshop on Determining the Need for and Developing a Strategy for a Neurotoxicity Testing Battery will be held Tuesday, May 19, 2009, at the Fairmont Hotel Vancouver in Vancouver, British Columbia, Canada. Sponsored by ASTM International Committee F04 on Medical and Surgical Implants and Materials and the U.S. Food and Drug Administration, the workshop will be held in conjunction with the May 19-22 standards development meetings of the committee.
This workshop will address the appropriate types and amount of neurotoxicity testing necessary to evaluate materials for use in medical devices in contact with neural tissue or cerebral spinal fluid. The main objectives of this workshop are:
--Identify standards development needs including any potential modifications to ASTM F748 and/or ISO 10993 to address neurological devices or materials;
--Begin to develop a consensus from FDA, academia, industry, medical professionals and professional societies on the least burdensome level of neurotoxicity testing and neurological device biocompatibility testing necessary to allow for the initiation of clinical studies and allow marketing clearance (510(k)s) or approvals (PMAs) for medical devices; and
--Use information and/or develop consensus standards from this workshop as the basis for future FDA neurological device biocompatibility guidance.
The invited presenters will come from academia, government and the medical device industry. The workshop will be structured as a series of short presentations followed by extended discussion on the following topics: neuro-biocompatibility, neurotoxicity and neuroinflammation assessment methods, in vivo perspectives on neurological device premarket testing and current regulatory strategies.
Online registration opens approximately eight weeks before the workshop and closes May 13. The fee to attend the workshop for ASTM members and non-members is $50 for online registration and $75 for on-site registration. The fee is waived for presenters and students with a valid I.D. For more information, including a technical program, visit the ASTM Web site at http://www.astm.org/MEETINGS/COMMIT/f04symp0509.htm.
Additional information is available from workshop chair Joseph A. Nielsen, Ph.D., U.S. Food and Drug Administration, Rockville, MD (phone: 301-796-0259 or 240-276-3621; joseph.nielsen@fda.hhs.gov).
Committee F04 is one of 140 ASTM technical standards-writing committees. Established in 1898, ASTM International is one of the largest international standards development and delivery systems in the world. ASTM International meets the World Trade Organization (WTO) principles for the development of international standards: coherence, consensus, development dimension, effectiveness, impartiality, openness, relevance and transparency. ASTM standards are accepted and used in research and development, product testing, quality systems and commercial transactions around the globe.
Contact:
Hannah Sparks
610-832-9677
hsparks@astm.org
