A Comprehensive Analysis of Postmarket Surveillance Study Orders: Device Characteristics, Study Statuses, Outcomes, and
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A Comprehensive Analysis of Postmarket Surveillance Study Orders: Device Characteristics, Study Statuses, Outcomes, and Potential Contributions
Therapeutic Innovation & Regulatory Science 1-11 ª The Author(s) 2020 https://doi.org/10.1007/s43441-020-00113-7
Chie Iwaishi, BS1, and Kiyotaka Iwasaki, PhD1,2
Abstract Background: The postmarket surveillance system plays a vital role in managing residual risks and identifying safety signals in realworld clinical practice. The Food and Drug Administration (FDA) can order postmarket surveillance studies when safety concerns are raised. We conducted a thorough investigation of device characteristics, study statuses, and the outcomes of US postmarket surveillance studies. Methods: As of April 2017, we identified 338 orders, corresponding to 394 studies using the FDA database. Additional searches were conducted to identify safety issues or reasons for orders. Results: Completed and active studies were limited. Fifteen of the 394 (3.8%) studies have been completed, and one study resulted in a recommendation of a labeling change. Forty-one (10.4%) studies were active. The majority of the studies (84.3%) were inactive. Three hundred fourteen (93%) orders were issued for implantable devices. The devices for use in women accounted for 144 (43%) orders. The mean from the first premarket approval or 510(k) clearance to 522 orders were 2968 days (n ¼ 9) and 3320 days (n ¼ 326), respectively, and the longest lag was 13,186 days. Conclusions: Our investigation highlighted that postmarket surveillance study orders resulted in the weeding out of many of the subject medical devices. There were little clinical data produced under the program. Timely and transparent feedback from the postmarket studies are critical for informed decisions by patients and medical practitioners and in expediting patient access to innovative or advanced medical devices. Keywords postmarket surveillance study, 522 Study, medical device safety, gynecology-obstetrics, real world data
Introduction Medical devices contribute to patients living longer and healthier when they are used appropriately. Whereas advancements in medical devices have contributed to saving and improving the quality of patients’ lives, serious adverse events associated with the use of some medical devices, such as metal-on-metal hip implants and implantable cardioverter-defibrillators have raised concerns about the effectiveness of the premarket review and postmarket surveillance system.1-3 In the United States and Japan, a clear trend has emerged toward expediting patient access to the innovative or advanced medical devices where probable benefits exceed probable risks.4,5 The 21st Century Cures Act that came into effect in December 2016 includes provisions designed to reduce clinical data required for device approvals to improve patients’ access.6,7 These regulatory directions that intend to accelerate patients’ access are built on premises with a robust postmarket surveillance system designed to capture critical safety signals
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