"This study demonstrates that very few 510(k) medical device submissions -- less than 0.5 percent -- become the subject of a Class I safety recall," Hall said.

Subcommittee Chair Joe Pitts (R-Pa.) asked Hall to explain why his findings were different from Nissen's results and the study's. After the hearing, Hall told DOTmed News he has four issues with the study.

Hall said it's inaccurate to just look at the numerator to see how the whole system is performing, explaining that Nissen's study didn't take the total number of devices going through the FDA's approval process into consideration. "Are there more Class I recalls for 510(k) products? Of course there are," said Hall. "Why? Because every year there are more than 3,000 510(k) submissions and 20 to 40 PMA submissions. Does it surprise you that there are more for the 510(k)?"

Another problem with the study is that researchers didn't look at the root causes of device recalls. "If you want to try to solve a problem, you need to know what caused the problem. And in my study, we looked at the reason for the recall and more than half of all the recalls were post-market problems, having nothing to do with the 510(k) system," Hall said.

"Even within the ones that may have existed at the time of clearance, the vast majority of those are quality system problems, not a lack of clinical data," he added.

Hall also said the researchers confused the classification of a product for its approval pathway with the classification of its recall. He used an example of a tongue depressor -- it's a low-risk product. If it's contaminated with deadly bacteria it's a high-risk recall. "They say that if it's a high-risk recall, it should be a high-risk PMA product. Those are two different things," Hall said.

Hall also said the study has "a number of misstatements about the law."

And the Medical Imaging & Technology Alliance, a major industry trade group, agrees with Hall. In a statement following the meeting, MITA expressed its support for improving the 510(k) approval process and criticized the study published in the Archives of Internal Medicine.

"The study uses a flawed analysis based on a simple count of the number of FDA recalls to draw inaccurate conclusions about the 510(k) process that would actually exacerbate the problem of timely patient access to innovative medical technologies," Dave Fisher, MITA's executive director, said in prepared remarks.

Innovate, but not at the expense of safety

Another panelist, Dr. Rita Redberg, said although the focus on medical innovation is important, the safety and effectiveness of the devices should be the leading factors of the FDA's device approval process.

More Industry Headlines