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

Chie Iwaishi, Kiyotaka Iwasaki

Research output: Contribution to journalArticlepeer-review

Abstract

Background:: The postmarket surveillance system plays a vital role in managing residual risks and identifying safety signals in real-worldclinical practice. The Food and Drug Administration (FDA) can order postmarket surveillance studies when safety concernsare raised. We conducted a thorough investigation of device characteristics, study statuses, and the outcomes of US postmarketsurveillance studies. Methods:: As of April 2017, we identified 338 orders, corresponding to 394 studies using the FDA database. Additional searcheswere 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 thesubject medical devices. There were little clinical data produced under the program. Timely and transparent feedback from thepostmarket studies are critical for informed decisions by patients and medical practitioners and in expediting patient access toinnovative or advanced medical devices.

Original languageEnglish
Pages (from-to)953-963
Number of pages11
JournalTherapeutic Innovation and Regulatory Science
Volume54
Issue number4
DOIs
Publication statusPublished - 2020 Jul 1

Keywords

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

ASJC Scopus subject areas

  • Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
  • Public Health, Environmental and Occupational Health
  • Pharmacology (medical)

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