Bioptics Inc, 3440 E Britannia Drive, Tucson, AZ 85706, USA.
Acad Radiol. 2010 May;17(5):652-7. doi: 10.1016/j.acra.2010.01.012.
Digital mammography is routinely used in the US to screen asymptomatic women for breast cancer and currently over 50% of US screening centers employ the technology. In spite of FDAs knowledge that digital mammography requires less radiation than film mammography and that its equivalence has been proven in a prospective randomized trial, the agency has failed to allow the technology market access via the 510(k) pre market clearance pathway. As a result of the restrictive Pre Market Approval process, only four suppliers have received FDA approval. The resulting lack of a competitive market has kept costs high, restricted technological innovation, and impeded product improvements as a result of PMA requirements. Meanwhile, at least twelve companies are on the market in the EU and the resulting competitive market has lowered costs and provided increased technological choice. A cultural change with new leadership occurred in the early 90's at FDA. The historical culture at the Center for Devices and Radiological Health of collaboration and education gave way to one characterized by a lack of reliance on outside scientific expertise, tolerance of decision making by unqualified reviewers, and an emphasis on enforcement and punishment. Digital mammography fell victim to this cultural change and as a result major innovations like breast CT and computer aided detection technologies are also withheld from the market. The medical device law, currently under review by the Institute of Medicine, should be amended by the Congress so that new technologies can be appropriately classified in accordance with the risk based assessment classification system detailed in Chapter V of the Federal Food, Drug, and Cosmetic Act. A panel of scientific experts chartered by the NIH or IOM should determine the classification appropriate for new technologies that have no historical regulatory framework. This would be binding on FDA. Unless the law is changed we will likely again experience additional debacles similar to that of digital mammography where important technology has been withheld from millions of women for more than a decade.
数字乳腺 X 线摄影术已在美国常规用于无症状妇女的乳腺癌筛查，目前超过 50%的美国筛查中心采用该技术。尽管美国食品药品监督管理局（FDA）知道数字乳腺 X 线摄影术比胶片乳腺 X 线摄影术所需的辐射量更少，并且其等效性已在一项前瞻性随机试验中得到证明，但该机构仍未能通过 510(k)预市场准入途径允许该技术进入市场。由于限制严格的上市前批准程序，只有四家供应商获得了 FDA 的批准。由于缺乏竞争激烈的市场，导致成本居高不下，限制了技术创新，并因 PMA 要求而阻碍了产品改进。与此同时，至少有十二家公司在欧盟市场上销售，竞争激烈的市场降低了成本，并提供了更多的技术选择。90 年代初，FDA 领导层发生了文化变革。设备和放射卫生中心的历史文化是合作和教育，现在则变成了一个不依赖外部科学专业知识、容忍不合格评审员做出决策、强调执法和惩罚的文化。数字乳腺 X 线摄影术成为这种文化变革的受害者，因此像乳房 CT 和计算机辅助检测技术等重大创新也被排除在市场之外。目前正在医学研究所（IOM）审查的医疗器械法应由国会进行修订，以便根据《联邦食品、药品和化妆品法》第五章详细规定的基于风险的评估分类系统，对新技术进行适当分类。NIH 或 IOM 委托的一个科学专家组应确定适用于没有历史监管框架的新技术的分类。这将对 FDA 具有约束力。除非法律得到修改，否则我们很可能再次经历类似数字乳腺 X 线摄影术的失败，其中重要的技术已被数百万妇女排除在外十多年。
