Zdrowie i gospodarka · 19.08.2009
Methodologies for Post-Approval Studies of Medical Devices; Public Workshop
The Food and Drug Administration (FDA) is announcing a public workshop entitled "Methodologies for Post-Approval Studies of Medical Devices." The purpose of the workshop is to facilitate discussion among FDA, industry, academia, professional societies, clinical investigators and other interested parties on issues related to methodologies for post-approval studies of medical devices. The target audiences for this workshop are Epidemiologists, Statisticians, Clinicians and Regulatory Affairs Specialists. Dates and Times: The workshop will be held on September 9, 2009, from 9 a.m. to 5 p.m. and September 10, 2009, from 9 a.m. to 5 p.m. Participants are encouraged to arrive early to ensure time for parking and security screening before the meeting. Security screening will begin at 8 a.m., and registration will begin at 8:30 a.m. Please pre- register for the workshop by following the instructions in this document. Location: The workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Silver Spring, MD 20993. Contact Persons: Daniel Ca[ntilde]os, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., WO66/Room 4120, Silver