Medical Devices - FDA Postmarket Safety Studies

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Transcript of 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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Abbreviations

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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


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