Zdrowie i gospodarka · 20.12.2005
Regulatory Process for Pediatric Mechanical Circulatory Support Devices (Ventricular Assist Devices)
The Food and Drug Administration (FDA) is announcing the following public meeting: Regulatory Process for Pediatric Mechanical Circulatory Support Devices (Ventricular Assist Devices). The topics of discussion are the agency's activities regarding the regulation and approval of circulatory support devices used for temporary support in pediatric patients. Date and Time: The public meeting will be held on January 20, 2006, from 9 a.m. to 12 p.m. The agency is requiring registration by December 30, 2005. Location: The public meeting will be held at the Center for Devices and Radiological Health, rm. 20B, 9200 Corporate Blvd., Rockville, MD 20850. Contact: Eric Chen, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., 301-443- 8262, ext. 146, e-mail: [email protected], or Michael Berman (HFZ-170), 12725 Twinbrook Pkwy., 301-827-4744, e-mail: [email protected]. If you need special accommodations due to a disability, please contact Eric Chen, at least 7 days in advance of the meeting. Registration: There is no fee to attend the workshop; however, because space is limited, registration is required. Please submit registration information