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A Comprehensive Analysis of Postmarket Surveillance Study Orders: Device Characteristics, Study Statuses, Outcomes, and Potential Contributions

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Abstract

Background:

The postmarket surveillance system plays a vital role in managing residual risks and identifying safety signals in real-world 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 = 9) and 3320 days (n = 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.

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  • 10 February 2020

    In the original article Fig. 3 is not displayed correctly. The corrected figure follows.

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Correspondence to Kiyotaka Iwasaki PhD.

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Iwaishi, C., Iwasaki, K. A Comprehensive Analysis of Postmarket Surveillance Study Orders: Device Characteristics, Study Statuses, Outcomes, and Potential Contributions. Ther Innov Regul Sci (2020). https://doi.org/10.1007/s43441-020-00113-7

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Keywords

  • postmarket surveillance study
  • 522 Study
  • medical device safety
  • gynecology-obstetrics
  • real world data