Public Health Effectiveness of the FDA 510(k) Clearance Process Measuring Postmarket Performance and Other Select Topics: Workshop Report (2011) / Chapter Skim
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Appendix C: 510(k) Premarket Notification Analysis of FDA Recall Data
Appendix C: 510(k) Premarket Notification Analysis of FDA Recall Data
Pages 73-96
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s affected by recall, 73.9% were recalled a single time and 26.1% were recalled more than once, including nearly 2% that were recalled more than five times.
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Recalls and Medical Device Reports represent surrogate markers of device reliability. A recall is an action taken to address a problem with a medical device that violates FDA law.2 Recalls occur when a medical device is defective and/ or when it could be a risk to health.
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. Methods 2.1.2 FDA Recall Database for Years 2003–2009 Consisted of all medical device recalls from January 1, 2003, to December 31, 2009.
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76 THE FDA 510(k) CLEARANCE PROCESS DATA ANALYSIS FIGURE C‑1 Annual number of 510(k)
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Advi sory Committees. · hile Advisory Committee assignments inform about the type of W devices cleared, the committees are rarely involved in the premarket 510(k)
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CLEARANCE PROCESS III I II FIGURE C‑3 510(k) device classification.
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s are submitted when a manufacturer makes modifica S tions to its own device, design control processes are appropriate, and design validation is performed. Abbreviated 510(k)
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CLEARANCE PROCESS FIGURE C‑5 510(k) implantable and life-sustaining features, 2003–2009.
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81 APPENDIX C FIGURE C‑6 Annual number of unique 510(k) s affected by recall.
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· mportantly, multiple recalls may be due to expansion of an initial re I call to additional products with the same potential defect and do not necessarily represent multiple modes of product failure. Additionally, because some 510(k)
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of the 510(k) bitmapped c-7 recalls occurring in 2003–2009 N were for products cleared in 1996–2002.
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· ecall-free survival estimates demonstrate that 98.4% of 510(k) s R cleared in 2003–2009 remained free of recall 1 year following the decision.
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. · he lowest recall rates are observed in years 5 and 6 post clearance T (0.9–1.1%)
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Recalls Cause Description Recalls (%) Manufacturing Manufacturing process inadequately controlled, 28.8 Process inadequate environmental controls, storage, packaging, labeling, equipment maintenance, material removal, etc.
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· any of the submissions that cite multiple predicates contain mul M tiple products (for example, submissions to the Office of In Vitro Diagnostic Device Evaluation and Safety [OIVD] for diagnostic tests)
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recalls, 2004–2009. · he age of the newest predicate Bitmapped T c-11 cited for 510(k)
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89 APPENDIX C FIGURE C‑12 Impact of 510(k) type on recall rate, 2003–2009.
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and more often cleared by the OIVD (32.1% vs 23.0%) cthan bitmpped -13 devices unaffected by recall.
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· here was a more than 3-fold increase in the percentage of Class III T devices among 510(k) s affected by recall compared to those unaf c-14 bitmapped fected (5.6% vs 1.7%)
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represented a lower percentage among recalled devices compared with devices unaffected by recall.
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· 9.5% of the reports are associated with a patient injury, although 2 <2% involve a patient death. · ata on MDRs are included in this report because they were specifi‑ D cally requested by the Institute of Medicine.
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s that were 4 subject to recall. · 0.0% of death adverse event reports, 34.0% of reported patient 3 c-16 bitmapped injuries, and 45.6% of device malfunction reports involving 510(k)
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s involving life sustaining devices and Class III devices.
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