Workshop on Determining the Need and Developing Strategy for a Neurotoxicity Battery May 19, 2009

SUMMARY: The Food and Drug Administration (FDA) is announcing its participation in an ASTM workshop entitled: Workshop on Determining the Need and Developing a Strategy for a Neurotoxicity Battery. FDA is co-chairing the workshop which is open to public participation.

BACKGROUND: Preclinical evaluation of medical devices is a complex process that involves careful evaluation of device biocompatibility. Inadequate preclinical evaluation of medical devices can lead to medical device related adverse events and complications. Evaluation of medical devices that contact neural tissue poses unique challenges due to the complexity of the nervous system. In addition, neural tissue has limited capacity for repair and high metabolic demands can make neural cells sensitive to toxicants. Current methods for evaluating neurotoxicity rely primarily on neuropathological and behavioral assessments. However, these approaches include a wide variety of methods and endpoints that can be difficult to interpret. The medical device industry, medical professionals and FDA have been unable to reach a consensus on what constitutes an appropriate level of preclinical testing for devices that contact neural tissue. The goal of this workshop is to begin to develop a consensus on an appropriate strategy for biocompatibility and neurotoxicity testing of medical devices that contact neural tissue.

WORKSHOP OBJECTIVES:

Begin to develop a consensus with standard development organizations, FDA, academia, industry and medical professionals on the least burdensome level of neurotoxicity and biocompatibility testing necessary to allow initiation of clinical studies and marketing clearance and approvals for medical devices that contact neural tissue.

Develop consensus guidelines for use as the basis of future FDA neurological device guidances.

Identify standards development needs including potential modifications to ASTM F748 and/or ISO10993 to address testing of neurological devices and materials.

DATES: The ASTM workshop co-chaired by FDA will be held on May 19, 2009; from 8:30 a.m. to 5:00 p.m. online registration opens March 2, 2009 and closes May 13, 2009. On site registration is available if you are not able to register online.

LOCATION: The Fairmont Hotel
900 West Georgia St
Vancouver, V6C 2W6, Canada
(604) 684-3131

FOR FURTHER INFORMATION CONTACT:

Joe Nielsen, Ph.D., 240-276-3605, joseph.nielsen@fda.hhs.gov
Additional information will be posted on this site following the meeting including meeting transcripts and presentation slides.

REGISTRATION: The online ASTM registration fee is $50 and the on site registration fee is $75.00. Register online at:  
http://www.astm.org