US Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD, USA.
US Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD, USA.
Value Health. 2020 Mar;23(3):294-297. doi: 10.1016/j.jval.2019.12.005. Epub 2020 Feb 29.
The US Food and Drug Administration is one of several US and global agencies making strides to incorporate patient preference information (PPI) into its decision making. PPI has been included in 5 completed medical device marketing decisions to date. Its usage is not more widespread because of uncertainty about how to design "fit-for-purpose" patient preference studies and a lack of standards for the choice of preference elicitation methods, among other reasons. To advance the application of PPI to decision making about medical devices, the Food and Drug Administration has published a guidance document, "Patient Preference Information-Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling." This article discusses key concepts in the guidance document, in addition to providing lessons learned from the use of PPI for medical device regulatory applications to date and identifying new opportunities to leverage PPI to elevate the patient voice in the medical device product life cycle.
美国食品和药物管理局是将患者偏好信息（PPI）纳入其决策制定过程的美国和全球多个机构之一。迄今为止，PPI 已纳入 5 项已完成的医疗器械营销决策中。由于对如何设计“适合目的”的患者偏好研究以及偏好 elicitation 方法的选择缺乏标准等原因，其使用并未更广泛。为了将 PPI 应用于医疗器械决策，美国食品和药物管理局发布了一份指导文件，“患者偏好信息-自愿提交、上市前批准申请、人道主义器械豁免申请和新器械请求的审查，以及纳入决策摘要和器械标签”。本文讨论了指导文件中的关键概念，此外还提供了迄今为止在医疗器械监管应用中使用 PPI 的经验教训，并确定了利用 PPI 在医疗器械产品生命周期中提升患者声音的新机会。
