Lewis T S
Medical Device Consultancy, Cardiff, UK.
Med Device Technol. 1996 Nov;7(9):24-30.
Delays in FDA product approvals have weakened the US medical device market. Reduced investment returns and the erosion of industry's confidence in FDA procedures have slowed the introduction of new products and threatened the market's potential for growth. This article examines the background to those issues and describes FDA's attempts to overcome its procedural shortcomings.
美国食品药品监督管理局（FDA）产品审批的延迟削弱了美国医疗器械市场。投资回报的降低以及行业对FDA审批程序信心的削弱减缓了新产品的推出，并威胁到市场的增长潜力。本文审视了这些问题的背景，并描述了FDA为克服其程序缺陷所做的努力。
