medical devices - fda postmarket safety studies
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September 2015
GAO-15-815
United States Government Accountability Office
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United States Government Accountability Office
September 2015
FDA Ordered Postmarket Studies to BetterUnderstand Safety Issues, and Many Studies AreOngoing
Why GAO Did This Study What GAO Found
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Page i GAO-15-815 Postmarket Studies of Devices
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Page ii GAO-15-815 Postmarket Studies of Devices
Abbreviations
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Page 1 GAO-15-815 Postmarket Studies of Devices
441 G St. N.W.Washington, DC 20548
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2014-2015 Strategic Priorities: Center for Devices and RadiologicalHealth
Strengthening Patient Care: Building an Effective National Medical Device SurveillanceSystem
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et al Journal of the
American Medical Association Internal Medicine .
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PostmarketSurveillance Under Section 522 of the Federal Food, Drug and Cosmetic Act: Guidancefor Industry and FDA Staff
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Table 1: Characteristics of the Food and Drug Administration’s (FDA) Postapproval and Postmarket Surveillance Studies forMedical Devices
Characteristic Postapproval study Postmarket surveillance study
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Table 2: Status Categories for Postapproval and Postmarket Surveillance Studies for Medical Devices
Status category Subcategory Definition
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Table 3: Medical Device Postapproval Studies by Medical Specialty, Ordered from January 1, 2007, through February 23, 2015
Medical specialty of device ExamplesNumber of studies
(percentage)
Total 313 (100)
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Fig. 1: Medical Device Postapproval Studies by Medical Specialty, Ordered fromJanuary 1, 2007, through February 23, 2015
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Fig. 2: Medical Device Postapproval Studies by Study Design, Ordered fromJanuary 1, 2007, through February 23, 2015
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Table 4: Data Sources for Medical Device Postapproval Studies, Ordered fromJanuary 1, 2007, through February 23, 2015
Data source Number of studies (percent)
Total 313 (100)
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Fig. 3: Status of Medical Device Postapproval Studies Ordered from January 1,2007, through February 23, 2015
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Proceduresfor Handling Postapproval Studies Imposed by PMA Order: Guidance for Industry andFDA Staff
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Table 5: Length of Ongoing and Completed Medical Device Postapproval StudiesOrdered from January 1, 2007, through February 23, 2015
In months (years)
Study status Number Minimum Maximum Mean
Total 287 N/A N/A N/A
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Fig. 4: Medical Device Postmarket Surveillance Studies by Medical Specialty,Ordered from May 1, 2008, through February 24, 2015
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Fig. 5: Status of Medical Device Postmarket Surveillance Studies Ordered from May 1, 2008, through February 24, 2015
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Table 6: Length of Ongoing and Completed Medical Device Postmarket SurveillanceStudies, Ordered from May 1, 2008, through February 24, 2015
In months (years)
Study status Number Minimum Maximum Mean
Total 48 N/A N/A N/A
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Draft Guidance: Procedures for Handling Section 522Postmarket Surveillance Studies
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Appendix I: GAO Contact and StaffAcknowledgments