title: Utilizing national and international registries to enhance pre-market medical device regulatory evaluation.
abstract: Regulatory decisions are made based on the assessment of risk and benefit of medical devices at the time of pre-market approval and subsequently, when post-market risk-benefit balance needs reevaluation. Such assessments depend on scientific evidence obtained from pre-market studies, post-approval studies, post-market surveillance studies, patient perspective information, as well as other real world data such as national and international registries. Such registries provide real world evidence and are playing a more and more important role in enhancing the safety and effectiveness evaluation of medical devices. While these registries provide large quantities of data reflecting real world practice and can potentially reduce the cost of clinical trials, challenges arise concerning (1) data quality adequate for regulatory decision-making, (2) bias introduced at every stage and aspect of study, (3) scientific validity of study designs, and (4) reliability and interpretability of study results. This article will discuss related statistical and regulatory challenges and opportunities with examples encountered in medical device regulatory reviews.
authors.affiliation: a Division of Biostatistics , Center for Devices and Radiological Health, U.S. Food and Drug Administration , Silver Spring , Maryland , USA.
authors.forename: Lilly Q
authors.initials: LQ
authors.lastname: Yue
authors.affiliation: a Division of Biostatistics , Center for Devices and Radiological Health, U.S. Food and Drug Administration , Silver Spring , Maryland , USA.
authors.forename: Gregory
authors.initials: G
authors.lastname: Campbell
authors.affiliation: a Division of Biostatistics , Center for Devices and Radiological Health, U.S. Food and Drug Administration , Silver Spring , Maryland , USA.
authors.forename: Nelson
authors.initials: N
authors.lastname: Lu
authors.affiliation: a Division of Biostatistics , Center for Devices and Radiological Health, U.S. Food and Drug Administration , Silver Spring , Maryland , USA.
authors.forename: Yunling
authors.initials: Y
authors.lastname: Xu
authors.affiliation: b Division of Cardiovascular Devices , Center for Devices and Radiological Health, U.S. Food and Drug Administration , Silver Spring , Maryland , USA.
authors.forename: Bram
authors.initials: B
authors.lastname: Zuckerman
mesh_terms: D015982:Bias; D000068598:Data Accuracy; D003657:Decision Making; D018795:Device Approval; D033161:Government Regulation; D006801:Humans; D012042:Registries; D015203:Reproducibility of Results; D012107:Research Design; D018570:Risk Assessment
keywords: Data quality; observational comparative studies; propensity score; registry; study design