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. 2015 Jan;8(1):124-31.
doi: 10.1161/CIRCOUTCOMES.114.001460. Epub 2015 Jan 6.

Medical device postapproval safety monitoring: where does the United States stand?

Prashant V Rajan  1 , Daniel B Kramer  1 , Aaron S Kesselheim  2
Affiliations

Medical device postapproval safety monitoring: where does the United States stand?

Prashant V Rajan et al. Circ Cardiovasc Qual Outcomes. 2015 Jan.
No abstract available

Keywords: United States Food and Drug Administration; equipment and supplies; product surveillance, postmarketing; registries.

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Figures

Figure 1
Figure 1
Status of Food and Drug Administration (FDA)–mandated postapproval studies (PAS) of medical devices. Information current as of June 2014. All 14 studies in 2014 and 22 of the 48 studies in 2013 are still pending. Other annual study totals include 31 in 2005, 45 in 2006, 25 in 2007, 37 in 2008, 29 in 2009, 27 in 2010, 42 in 2011, and 55 in 2012. Definitions of study statuses: completed=manufacturer has fulfilled condition of approval and FDA has closed the study; progress adequate=study is progressing in accordance with the PAS protocol; progress inadequate=study is not progressing in accordance with the PAS protocol (eg, not meeting enrollment and timeline schedules, not adequately following up with patients, and not evaluating all end points); terminated=manufacturer has not fulfilled or cannot fulfill the PAS order for various reasons (eg, device is no longer being sold or has been changed, study questions are obsolete, manufacturer is no longer seeking premarket approval, study is not designed to answer relevant questions), all efforts to fulfill the PAS have been exhausted and the study has been terminated; study pending=the manufacturer's study protocol has been approved and the FDA is awaiting the first progress report; other=the study does not fit within another category (eg, study has changed leadership, device is being redesigned, a separate study is being used).
Figure 2
Figure 2
Status of Food and Drug Administration (FDA)-mandated 522 studies of medical devices. Information current as of June 2014. No studies in 2007 and 2008 were present in the database. Only 1 study was mandated in 2001, 2004, and 2005, with all 3 studies having been completed. In 2006, 2 studies were orders with 1 completion and 1 still showing inadequate process. Other annual study totals include 17 in 2009, 14 in 2010, 179 in 2011, 123 in 2012, and 45 in 2013. Definitions of study statuses: completed=manufacturer has fulfilled postmarket surveillance 522 order and FDA has closed the study; progress adequate=study is progressing in accordance with the 522 plan; progress inadequate=study is not progressing in accordance with the 522 plan (eg, not meeting enrollment and timeline schedules, not adequately following up with patients, and not evaluating all end points) or the study plan is overdue; terminated=manufacturer has not fulfilled or cannot fulfill the 522 order for various reasons (eg, device is no longer being sold or has been changed, study questions are obsolete, manufacturer is no longer seeking premarket approval, study is not designed to answer relevant questions), all efforts to fulfill the 522 have been exhausted and the study has been terminated; study pending=the manufacturer's study protocol has been approved and the FDA is awaiting the first progress report; other=the study does not fit within another category (eg, study has changed leadership, device is being redesigned, a separate study is being used).
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References

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