Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in the MedTech Insight Pharma Intelligence, in “An FDA Age-Based Predicate Policy Would Be Arbitrary, Reg Experts Complain,” by Elizabeth Orr and David Filmore. (Read the full version – subscription required.)
Following is an excerpt:
There are still many details to be worked out with US FDA’s plans to reform the 510(k) process, but expert observers suggest the agency’s focus on favoring newer predicates may result in arbitrary policies.
The agency floated reform proposals last month, including the possibility of publishing a list of all cleared devices that had been based on predicates more than a decade old as a means to encourage companies to adopt new predicates to support 510(k) devices. FDA also said it was considering policies to more formally “sunset certain older predicates and promote the use of more modern predicates,” as it also moves toward finalizing an alternative 510(k) pathway that relies on performance criteria rather than device-to-device comparisons.
FDA’s emphasis on the age of a predicate may be misguided, several attorneys and medtech regulatory experts suggest, pointing out that there is not a generally applicable cut-off for when a predicate can be considered too old.
The agency makes clear that it is not arguing that a device cleared based on a predicate that is more than 10 years old is inherently unsafe. But, it argues, the fact that nearly 20 percent of current 510(k)s are cleared based on a predicate that’s more than a decade old “does mean that some devices may not be continually improving, which is the hallmark of health technologies.” …
Bradley Merrill Thompson, an attorney with Epstein Becker & Green, argued that FDA hasn’t established that devices using predicates more than 10 years old are less safe as a group than those with newer predicates.
“The selection of a predicate is a very important decision, but only in the sense that there must be a predicate,” he said. “Beyond the existence of a predicate, submissions must demonstrate compliance to any special controls FDA has adopted.” …
Thompson believes FDA could address problematic predicates in a more targeted manner via special controls on the affected devices. …
“A regulatory agency is not imbued with the power to create law outside of the parameters set by Congress,” attorney Thompson write in response to the recent proposals. “An agency that proposes a pathway that contradicts or exceeds congressional directive expressed in statute violates the law.”
Thompson says that FDA’s proposals would rewrite the 1976 legislation that created the 510(k) process. He acknowledged that FDA suggested some of its proposals might require congressional intervention, but Thompson said that wasn’t enough. …
But Thompson argued that listing products relying on older predicates would violate US Department of Health & Human Services rules around the release of information, he says. The HHS regs require that information that is released is accurate and “fulfills an authorized purpose.” A public release of merely a list of those products using older predicates does not accurately convey the safety and effectiveness profile of the products on the list,” Thompson says.
