In reply Fogarty draws the same erroneous conclusion as Connor et al,1 saying that the reason why the number of high-risk recalls are primarily from devices cleared through the 510(k) process rather than the more rigorous PMA process is because most devices go through the 510(k) process. However, the problem is not the number of recalls, it is the number of high-risk recalls of devices that the FDA concludes could cause death or serious permanent harm. Current law requires the FDA to use their more rigorous PMA review if a medical device is life sustaining or otherwise high risk.2 And yet, our study found that most recalls of potentially deadly devices were for devices that had been cleared through the 510(k) process as low or moderate risk.3 Most of these high-risk recalls are caused by predictable problems, such as implants that break or diagnostic tests that are inaccurate. The more rigorous PMA process would have been more likely to identify risks in a clinical trial, inspection of the manufacturing facility, or required postmarket study. All those safeguards are absent in the 510(k) process. We agree with Fogarty that the 510(k) process has always been the dominant mechanism for new device clearance. Nevertheless, a mechanism to approve devices that were “substantially equivalent” to devices on the market in 1976 was expected to be used less often as pre-1976 devices became obsolete. Instead, the definition of substantial equivalence was revised so that more devices could qualify. Fogarty correctly stated that the definition was changed in the 1990 Safe Medical Device Act; however, the definition has subsequently been interpreted so loosely that even the FDA admits they need to “clarify the meaning of ‘substantial equivalence.’”4 Fogarty is correct that the least burdensome approach was introduced in the 1997 FDA Modernization Act, and we were correct that it was implemented in 2002, when the final rule was issued. We stand by our statement that devices that were cleared as a 510(k) or approved as a PMA can serve as predicate devices. The FDA explains that a predicate can include “a device that was originally on the US market as a Class III device (Premarket Approval) and later down classified to Class II or I.”5 Our brief historical review did not attempt to describe the many revisions to the 510(k) process, but consistent with our conclusions that standards have loosened over time, the Government Accountability Office found that the FDA did not tighten the process, repeatedly failing to implement the 1990 law requiring that all high-risk devices be subject to PMA rather than 510(k) review.6 That failure led to deaths and serious injuries from defective automated external defibrillators and pedicle screw spinal systems, for example.6 The fact remains that most high-risk recalls are of devices that the FDA had erroneously categorized as low or moderate risk, and this has resulted in more than half a billion very dangerous devices being recalled since 2005.7 Our findings are consistent with the Institute of Medicine's 2011 conclusions that 510(k) clearance is “not a determination that the cleared device is safe or effective.”8(p2) Back to top Article Information Correspondence: Dr Zuckerman, National Research Center for Women & Families, 1701 K St NW, Ste 700, Washington, DC 20006 (firstname.lastname@example.org). Financial Disclosure: None reported. References 1. Connor JT, Lewis RJ, Berry DA, Berry SM. FDA recalls not as alarming as they seem. Arch Intern Med. 2011;171(11):1044-104521670380PubMedGoogle ScholarCrossref 2. Wizemann T, ed. Public health effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Institute of Medicine Workshop report. http://www.nap.edu/catalog.php?record_id=12960. Accessed March 28, 2011 3. Zuckerman DM, Brown P, Nissen SE. Medical device recalls and the FDA approval process. Arch Intern Med. 2011;171(11):1006-101121321283PubMedGoogle ScholarCrossref 4. US Food and Drug Administration. 510(k) Working Group preliminary report and recommendations. August 2010. Http://www.fda.gov/downloads/aboutfda/centersoffices/CDRH/cdrhreports/UCM220784.pdf. Accessed June 6, 2011 5. US Food and Drug Administration. How to Find a Predicate Device. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134571.htm. Accessed June 6, 2011 6. Crosse M, Devices M. FDA's premarket review and postmarket safety efforts, testimony before the Special Committee on Aging, US Senate. April 13, 2011. Publication No. GAO-011-556T. http://www.legistorm.com/score_gao/show/id/41054.html. Accessed June 3, 2011 7. Zuckerman DM, Brown P, Nissen SE. FDA recalls not as alarming as they seem [in reply]. Arch Intern Med. 2011;171(11):1045-1046Google ScholarCrossref 8. Medical Devices and the Public's Health. The 510(k) clearance process at 35 years, Institute of Medicine, report brief. July 2011. http://www.iom.edu/Reports/2011/Medical-Devices-and-the-Publics-Health-The-FDA-510k-Clearance-Process-at-35-Years.aspx. Accessed October 18, 2011
Archives of Internal Medicine – American Medical Association
Published: Nov 28, 2011
Keywords: medical devices
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