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首页> 外文期刊>JAMA: the Journal of the American Medical Association >FDA Approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012
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FDA Approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012

机译：1979-2012年，FDA通过原始和补充上市前批准途径批准了心脏植入式电子设备

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IMPORTANCE: The US Food and Drug Administration (FDA) evaluates high-risk medical devices such as cardiac implantable electronic devices (CIEDs), including pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy devices, via the premarket approval (PMA) process, during which manufacturers submit clinical data demonstrating safety and effectiveness. Subsequent changes to approved high-risk devices are implemented via "supplements," which may not require additional clinical testing. OBJECTIVE: To characterize the prevalence and characteristics of changes to CIEDs made through the PMA supplement process. DESIGN: Using the FDA's PMA database, we reviewed all CIEDs approved as original PMAs or supplements from 1979 through 2012. For each supplement, we collected the date approved, type of supplement (panel-track, 180-day, real-time, special, and 30-day notice), and the nature of the changes. We calculated the number of supplements approved per PMA and analyzed trends relating to different supplement regulatory categories over time. For supplements approved via the 180-day regulatory pathway, which often involve significant design changes, from 2010-2012, we identified how often additional clinical data were collected. RESULTS: From 1979-2012, the FDA approved 77 original and 5829 supplement PMA applications for CIEDs, with a median of 50 supplements per original PMA (interquartile range [IQR], 23-87). Excluding manufacturing changes that do not alter device design, the number of supplements approved each year was stable around a mean (SD) of 2.6 (0.9) supplements per PMA per year. Premarket approvals remained active via successive supplements over a median period of 15 years (IQR, 8-20), and 79% of the 77 original PMAs approved during our study period were the subject of at least 1 supplement in 2012. Thirty-seven percent of approved supplements involved a change to the device's design. Among 180-day supplements approved from 2010-2012, 23%(15/64) included new clinical data to support safety and effectiveness. CONCLUSIONS AND RELEVANCE: Many CIED models currently used by clinicians were approved via the PMA supplement process, not as original PMAs. Most new device models are deemed safe and effective without requiring new clinical data, reinforcing the importance of rigorous postapproval surveillance of these devices.
机译：重要提示：美国食品药品监督管理局（FDA）通过上市前批准（PMA）流程评估了高风险医疗设备，例如心脏植入式电子设备（CIED），包括心脏起搏器，植入式心脏复律除颤器和心脏再同步治疗设备，在此期间，制造商提交了证明安全性和有效性的临床数据。批准的高风险设备的后续更改通过“补充”实施，可能不需要进行额外的临床测试。目的：描述通过PMA补充程序对CIED进行更改的普遍性和特征。设计：使用FDA的PMA数据库，我们审查了从1979年到2012年所有被批准为原始PMA或补品的CIED。对于每种补品，我们收集了批准日期，补品类型（跟踪，180天，实时，特殊，以及30天的通知），以及更改的性质。我们计算了每个PMA批准的补品数量，并分析了随着时间推移与不同补品监管类别相关的趋势。对于通过180天监管途径批准的补充剂（通常涉及重大的设计变更），我们从2010年至2012年确定了收集其他临床数据的频率。结果：从1979年至2012年，FDA批准了CIED的77份原始PMA和5829份PMA申请，每份原始PMA中位数为50份（四分位间距[IQR]，23-87）。除了不改变设备设计的制造变更外，每年批准的补充剂数量稳定在每PMA每年2.6（0.9）个补充剂的平均（SD）左右。上市前批准通过连续15年的中位补充（IQR，8-20）保持活跃，并且在我们的研究期间，批准的77个原始PMA中的79％在2012年至少被补充了1个。37％批准的补品中涉及对设备设计的更改。在2010年至2012年批准的180天补品中，有23％（15/64）包括支持安全性和有效性的新临床数据。结论和相关性：目前临床医生使用的许多CIED模型都是通过PMA补充程序批准的，而不是原始的PMA。大多数新设备模型被认为是安全有效的，不需要新的临床数据，从而加强了对这些设备进行严格的批准后监视的重要性。

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