Study Reveals Less Than 1 Percent of Medical Devices Cleared by 510(k) Process Were Involved in Class 1 Recalls


The Advanced Medical Technology Association (Advamed) recently released an assessment of the safety record of medical devices cleared by the Food & Drug Administration’s 510(k) process. In the face of the FDA’s consideration of approximately 70 changes to the 510(k) process, the analysis conducted by Massachusettes based Battelle Memorial Institute indicates that additional premarket review requirements may not significantly increase device safety by examining the number of recalls during a five-year period ending in May 2010. Further, evidence indicates that the proposed changes may cause undue delay and disruption to the program that would harm more than help the partners they are designed to protect.

According to the FDA, a recall is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device, according to the FDA, is defective, when it could be a risk to health, or when it is both defective and a risk to health.  Manufacturers institute recalls to correct problems or remove products from the market. The FDA classifies medical device recalls into three categories, representing the potential risk to public health: Class I, Class II, and Class III. This classification process usually takes place after the company has issued its recall.

  • Class I—high risk
  • Class II—less-serious risk
  • Class III—low risk

Class I recalls, being the most serious,  involve a “situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death”. Recalls may be conducted on a manufacturer’s own initiative, by FDA request, or by FDA order under statutory authority. Class I recalls can be issued for medical devices, drugs, biologics, and food.

According to the Battelle study, 46,690 devices have been cleared through the 510(k) process since 1998—the year certain low-risk medical devices began to be exempted from premarket notification requirements (as part of The Food and Drug Administration Modernization Act (FDAMA)). During this same time period, 2,825 devices have been approved through the Premarket Approval (PMA) process. This total includes PMA supplements representing significant changes: 180-day supplements and panel track supplements. Of this pool of devices, during a five-year period from January 2005 to May 2010, 24 Class I Recalls of PMA approved devices occurred.  This equates to .85% of the total PMA approved devices cleared during the benchmark period.  During the same five-year period, 77 Class I Recalls occurred of devices cleared through the 510(k) process. This equals approximately .16% of the total 510(k)-cleared devices during the five-year period.

Interestingly, approximately 50% of the recall causes of 510(k)-cleared devices (representing less than 0.1% of all 510(k) clearances since 1998) in the Battelle study’s review period were attributed to design deficiencies [defined in the study as having to do with flaws inherent in the design either initially or through approved design changes], 29% to manufacturing deficiencies [i.e. failure to maintain sterility, failure to follow GMPs or QC issues], and 6% to labeling deficiencies [although these may be derived from a manufacturing or design root cause].  The remaining 15% of 510(k)-cleared device recall causes were classified as ― “design or manufacturing,” as data were not available to make a determination with a reasonable degree of confidence.

Of the three regulatory classes based on the level of control necessary to ensure the safety and effectiveness of the device, 61% of the class I recalls were Class II devices, 28% Class III devices, and 4% Class I devices, with 7% being undefined. 

The study complements the results of two recently released studies that also highlight the strong safety record of FDA’s 510(k) review process. Ralph Hall, PhD, of the University of Minnesota in Minneapolis found that the rate of Class I recalls for 510(k)-cleared products was less than 0.2%. Another study by William H. Maisel, MD, from Beth Israel Deaconess Medical Center in Boston, looked at all classes of recalls and found a recall rate in the range of 1.0 to 1.5%.

The quantitative data of the Battelle study provides important information as the FDA moves forward with some of the more than 70 recommended changes it is considering to the program.

Recent FDA statistics have shown a deterioration in the efficiency of the 510(k) process. The FDA’s recommendations regarding increased reviewer training, development of additional guidance, and greater communication of reviewer decision rationale could address these deficiencies that result in delays of inconsistencies in the program, according to AdvaMed.  Moreover, some the proposed changes to the process by the FDA could fundamentally alter basic definitions and submission requirements of the 510(k) process. Taken together, these changes could significantly disrupt the program and delay patient access to needed medical innovations. As such, most recently, the 12 members of the House Energy and Commerce Committee sent a letter to the FDA urging the agency to prioritize its rulemaking to focus on recommendations that have the support of interested parties and encouraged maintenance of a "...well-functioning, efficient system that both fosters innovation and ensures patient safety...."

Daniel S. Wittenberg

As a partner of Snell & Wilmer, Dan Wittenberg concentrates his practice in representing medical device, pharmaceutical, biotechnology, consumer product and heavy equipment manufacturers in product liability litigation as well as counseling these companies in risk management strategies, recalls and in responding to regulatory agency inquiries. Dan has attained certification as a Global Regulatory Affairs Compliance Professional (GRACP) in order to further assist life science and medical technology companies with FDA and regulatory issues and has also served as national counsel for major medical device manufacturing concerns and regional counsel in mass tort cases. He also represents companies in commercial litigation and works with entities in technology transfer and intellectual property matters.

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