A new study on the 510(k) process missed the mark and drew the ire of industry groups AdvaMed and the Medical Imaging & Technology Alliance (MITA). A colleague says the study “compares apples to kumquats,” meaning, of course, that the data used in the study should not even have been compared to one another in the first place. AdvaMed and MITA both say the study contains factual errors, faulty data analysis, and recommendations that would harm patient access to medical technology with no corresponding safety benefit.

MITA reamed the study, “Medical Device Recalls and the FDA Approval Process,”  published in February by Diana Zuckerman, et al., saying that it contains dangerous recommendations that, if adopted, would add unnecessary and burdensome hurdles to bringing safe and innovative products to market.

“Simply put, this paper is seriously flawed and inconsistent with three previous analyses of the same data set conducted by respected researchers,” says AdvaMed’s Stephen J. Ubl, president and CEO  in reaction to the study.

The study, led by Zuckerman at the National Research Center for Women & Families and published in the Archives of Internal Medicine, looks at the number of recalls for a subset of devices cleared by the FDA’s 510(k) process, the process used to review and clear devices that are similar to those that have already been cleared by FDA as safe and effective. It was cited by a number of news organizations including the Wall Street Journal,  the New York Times, and the Los Angeles Times. Unfortunately, this is how misinformation often gets to the public without being vetted by industry.

"Because of an elementary error in data analysis, the conclusions drawn from the study are faulty, and the paper is marked by a large number of factual errors and misleading inferences. Adoption of the paper’s recommendations would actually harm American patients by further delaying access to safe and effective treatments, says Ubl.”

Ubl noted that “three recent studies have all found that the 510(k) process has a remarkable safety record with extremely low recall rates—one study reported a rate of less than two-tenths of one percent.”

While the findings of the new study indicate that a higher number of 510(k) medical devices are recalled than products cleared through the premarket approval (PMA) process, MITA says that the authors failed to put these numbers in context, noting that there are more than 3,000 devices and diagnostics cleared through the 510(k) process every year compared to 20-40 products cleared through the PMA process. Based on their limited analysis, the authors recommended that the FDA overhaul this clearance process and send more devices through the FDA’s more costly PMA.

“A real concern at FDA is the growing lack of predictability and consistency in product reviews, needlessly delaying patient access to safe and effective diagnostics and treatments,” says Ubl.  He says that  foreign patients benefit from new treatments two to three years sooner than US patients, even when those treatments are invented and manufactured right here in the United States.

MITA agrees.  “The Zuckerman study draws inaccurate conclusions based on a simple count of the number of FDA recalls. This irresponsible research method led to potentially harmful claims and recommendations about a clearance process that in fact has an excellent track record for clearing safe and effective products,” says Dave Fisher, executive director of the MITA.  “Interestingly, the study actually appears to add evidence to the argument that products approved through the 510(k) process are just as safe—if not safer—than those devices approved through the lengthy PMA process.”

Furthermore, MITA says that the Zuckerman analysis looked at Class I recalls for high-risk devices and used those numbers to question all 510(k) devices, unjustifiably recommending changes to the clearance process for all classes of devices, including devices that are low-risk, such as medical imaging technologies.

Fisher notes that the 510(k) clearance program has a track record of protecting public health, but as manufacturers innovate diagnostic technologies, the clearance process will have to improve so that it can continue to spur innovation. ”MITA remains committed to working with the FDA to identify efficiencies in the 510(k) process so that patients are never denied the latest treatment,” he says.

“While the overall safety record of the 510(k) system is excellent, there is always room for improvement. The 510(k) reform implementation plan recently announced by the FDA provides for improving reviewer and manager training, establishing a Center Science Council to ensure consistency in the review process, issuing more guidance documents to provide greater clarity to manufacturers, and applying additional requirements on a targeted basis. This is the right way to improve a process that has a demonstrated safety record for more than 30 years and is fundamentally sound,” says Ubl.