Miscellaneous| Volume 113, ISSUE 11, P1899-1903, June 01, 2014

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Assessment of Cardiovascular and Noncardiovascular Medical Device Recalls

      Medical device recalls have called attention to the device approval process in the United States. The premarket approval (PMA) process requires clinical trials to evaluate safety and effectiveness, whereas the expedited 510(k) process does not. The 510(k) process has been considered a source of increased recalls. This study aimed to assess the relative safety of medical device approval pathways based on the numbers of approvals and recalls. Data on recalls in the United States from January 2005 to December 2012 were collected from the Food and Drug Administration Web site. Over 8 years, 30,002 devices were approved, 5,728 by PMA (19%) and 24,274 (81%) by 510(k). There were 249 recalls due to serious risks, 0.45% of PMA approvals, and 0.92% of 510(k)-cleared devices, p <0.001. Over 1/2 of the recalls were during the first 2 years on the market. Percentage of recalled PMA devices was unchanged over the 8 years, whereas 510(k) recalls increased in 2010 to 2012 (from 0.65% to 1.39%, p <0.001). Cardiovascular devices represent the largest class of recalls (27%). The proportions of recalled PMA and 510(k) cardiovascular devices were the same as for all medical devices until 2011, but 510(k) recalls dramatically decreased in 2012 to the lowest recall rate seen (0.73%). In conclusion, recall rates were the same for 510(k)- and PMA-approved devices in 2005 to 2009 and increased for 510(k) devices subsequently. Modifying the 510(k) process with more rigorous performance testing, a conditional 2-year approval and a mandatory registry may be an approach to reduce recalls.
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        • Schoonmaker Michele
        The U.S. Approval Process for Medical Devices: Legislative Issues and Comparison with the Drug Model.
        CRS Report for Congress, 2005 (RL32826:1-39 (Last accessed on February 11, 2014 at)
        • Johnson Judith A.
        FDA Regulation of Medical Devices.
        CRS Report for Congress, 2012 (R42130;1-33 (Last accessed on February 11, 2014 at)
        • Zuckerman D.M.
        • Brown P.
        • Nissen S.E.
        Medical device recalls and the FDA approval process.
        Arch Intern Med. 2011; 171: 1006-1011
        • Resnic F.S.
        • Normand S.L.
        Postmarketing surveillance of medical devices—filling in the gaps.
        N Engl J Med. 2012; 366: 875-877
        • Hauser R.G.
        Here we go again—failure of postmarketing device surveillance.
        N Engl J Med. 2012; 366: 873-875
        • Ardaugh B.M.
        • Graves S.E.
        • Redberg R.F.
        The 510(k) ancestry of a metal-on-metal hip implant.
        N Engl J Med. 2013; 368: 97-100
        • Curfman G.D.
        • Redberg R.F.
        Medical devices—balancing regulation and innovation.
        N Engl J Med. 2011; 365: 975-977
        • Suter L.G.
        • Paltiel A.D.
        • Rome B.N.
        • Solomon D.H.
        • Golovaty I.
        • Gerlovin H.
        • Katz J.N.
        • Losina E.
        Medical device innovation—is “better” good enough?.
        N Engl J Med. 2011; 365: 1464-1466
        • Challoner D.R.
        • Vodra W.W.
        Medical devices and health—creating a new regulatory framework for moderate-risk devices.
        N Engl J Med. 2011; 365: 977-979
        • Institute of Medicine
        Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years.
        National Academies Press, Washington, DC2011: 1-206 ((Last accessed on February 11, 2014 at)
      1. US Food and Drug Administration. FDA News Release, (July 29, 2011). (Last accessed on February 11, 2014 at

      2. AdvaMed Statement on IOM 510(k) Report. Press release, (July 29, 2011). (Last accessed on February 11, 2014 at

      3. FDA Medical Device Approvals and Clearances. (Last accessed on February 11, 2014 at

      4. US Food and Drug Administration. List of Device Recalls. (Last accessed on February 11, 2014 at

      5. US Food and Drug Administration. Medical and Radiation-Emitting Recalls. (Last accessed on February 11, 2014 at

      6. FDA- Manufacturer and User Facility Device Experience (MAUDE) search engine. (Last accessed on February 11, 2014 at