Shortly after the formal statement by William Maisel, MD, the FDA advisory panel left for floor votes and never reconvened.
Maisel, director of the Medical Device Safety Institute (Boston), told Medical Device Daily that he has a couple of problems with the device approval processes at CDRH. "One is that there's some ambiguity in the regulations" that determine "what types of changes should be slotted into which [PMA] categories."
He said, "device design changes are explicitly mentioned in both the panel track and 180-day PMA supplements." Panel-track supplements "require clinical data and the 180-day supplements usually do not," Maisel noted, but observed that FDA "almost always puts them in the 180-day" category. "This is an example of the latitude and ambiguity in the regulations."
While FDA needs some latitude, Maisel said, "in my view, the bar for some of these – the Sprint Fidelis being the poster child – needs to be raised."
"The 510(k) process needs to be changed," Maisel asserted, adding that the changes he would like to see "are important and not revolutionary changes," such as reclassification of the pre-amendment devices.
Maisel mentioned that the controversy over the Edwards Lifesciences (Irvine, California) Myxo ETLogix annuloplasty ring highlights what he sees as a hole in the 510(k) mechanism.
"The point that this brings up is that there's a guidance on the 510k process that allows companies to make changes to their product, and if it doesn't introduce – in the company's opinion – any safety issues," the sponsor can move forward unilaterally and FDA has little opportunity to intervene.
"Clearly that loophole needs to be closed," he said, stating further that "there should be a requirement that FDA ... at least have knowledge that those [altered] devices are out there," but ideally that some of the changes in question be reviewed by FDA.
— Mark McCarty, Washington Editor