The Center for Devices and Radiological health: an update.
At a recent medical device conference, Dr. David Feigal, the Director of the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) stated that one-third of the CDRH staff will retire in five years. This is only one of many challenges that the Center faces.This article discusses key factors shaping current FDA device policies and programmes, the CDRH strategic plan, the continuing importance of the standards programme, and CDRH harmonisation activities.
Donawa
M
M
Donawa & Associates Ltd, Rome, Italy. donawa@srd.it
D018795:Device Approval / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D033161:Government Regulation; D009937:Organizational Objectives; D011870:Radiologic Health / Q000458:organization & administration*; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration*