“We made a point that just because a device met those criteria, that it might not fall into [the higher-risk category], because it might have been on the market for a long time and demonstrated a good safety profile historically, so there would be no need to put it into a 2b,” Janet Trunzo, executive vice president for technology and regulatory affairs for AdvaMed, told DOTmed News.

In its comments on the proposed changes submitted to the FDA in early October, AdvaMed said while it supported close to one-third of the proposed changes, its main fear was that cumulatively, many of the new changes could increase the burden on companies, making it that much harder and more expensive to get devices approved.


Already, the industry is grumbling that despite increases in user fees – money collected from device companies to help the FDA pay for its operations – the clearance process has gotten slower and slower. Largely, this has come about because of the agency ordering increasing numbers of review cycles, according to AdvaMed, which can add months to the allotted time the agency has to review a product submission.

“What happens is, a review cycle is when FDA stops the review clock and asks for more information, and then upon receipt of that they restart the clock,” Trunzo explained.

She said over the years it went from 1.4 review cycles per submission to now close to two per submission.

“We don’t have any data or analysis from FDA as to why they’re stopping the review clock,” she said. “But stopping the review clock does lengthen the review process.”

Safety under scrutiny
As part of its opposition to some of the changes, AdvaMed points out that the 510(k) process works, and that its safety has been upheld by numerous studies.

An analysis by Battelle Memorial Institute commissioned by the group this summer found of the 47,000 devices cleared by the process since 1998, only 0.16 percent were involved in a Class 1 recall – that is, a recall in which the products involved had the potential to cause serious injury or death.

The group says this echoes two other recent studies, one from Ralph Hall of the University of Minnesota and one from Dr. William Maisel of Beth Israel Deaconess Medical Center. Hall's study found that the rate of Class I recalls for 510(k)-cleared products was less than one out of 500. Maisel's study looked at all classes of recalls and found a recall rate in the range of one out of 100, to one out of 67.

"The 510(k) process has an extraordinary safety record," AdvaMed’s senior executive vice president David Nexon told reporters in a call last month. "It's hard to imagine that any other regulatory process has as good a record at weeding out products before reaching patients."

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