Industry study affirms safety of FDAs 510(k) review process

A study released by Advanced Medical Technology Association (AdvaMed) reaffirms the safety record of FDA’s premarket review process for low- and moderate-risk devices, known as the “510(k)” process. The study, conducted by the research firm Battelle Memorial Institute for AdvaMed, demonstrates that of the nearly 47,000 medical devices cleared by FDA through the 510(k) process since 1998, only 0.16 percent were involved in a serious recall event.

Analyzing publicly available information from both FDA and companies with affected products, Battelle based its calculation on the 77 Class I recalls FDA reported from January 2005 through May 2010. Class I recalls involve products that have the potential to cause serious health problems.

This analysis also provides evidence that additional premarket review requirements would not likely increase device safety significantly. The study found that only 0.08 percent of devices cleared via 510(k) since 1998 were recalled for design reasons that might have been detected during premarket review, according to AdvaMed, a Washington, D.C.-based industry group composed of medical device, diagnostic product and health information systems companies.

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 percent. 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 percent.

The quantitative data of the Battelle report provides important information as 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. 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 and inconsistencies in the program, according to AdvaMed.

However, FDA is proposing more than 70 changes, some of which 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, AdvaMed stated.

A copy of the Battelle study is available here.