Regulatory Development of the Year: 510(k) changes inch along

After a decade serving at the head of FDA’s Center for Devices and Radiological Health, […]

After a decade serving at the head of FDA’s Center for Devices and Radiological Health, the 510(k) program looks significantly different from when director Jeff Shuren first stepped into the role. With more than 80% of devices cleared or approved through the pathway, small changes can be consequential in moving the needle to improve the safety of medical devices.
New efforts by FDA to build out the program this year come after the Institute of Medicine recommended the agency scrap it altogether in 2011.
The IOM report called the 510(k) program “flawed based on its legislative foundation,” recommending FDA develop a new integrated framework to provide a “reasonable assurance of safety and effectiveness throughout the device life cycle.”
Instead, Shuren has made the pursuit of a total product life cycle approach a key component of FDA’s efforts to enhance device safety, launching a reorganization and operationalizing its new Office of Product Evaluation and Quality this year.
The agency also took steps to issue several guidances, including on its Safety and Performance Based Pathway, Special 510(k) Program, its refuse to accept policy for 510(k)s, and updates to formatting for traditional and abbreviated 510(k) submissions.
Mike Carome, director of Public Citizen’s Health Research Group is not convinced these steps will be enough, even if companies utilize the new material FDA has published this year.
“I think the 510(k) process is so flawed. Even with some of the changes, they are not going to substantially change the regulatory oversight of medical devices or improve it in any way,” Carome said.
But researchers Vinay Rathi and Joseph Ross recently wrote in The New England Journal of Medicine that in recent years, FDA has worked to eliminate “troublesome practices that had been allowed under the 510(k) pathway.”
“The FDA has been criticized for rarely requiring clinical evidence before device clearance, but this approach is often prudent,” Rathi and Ross wrote in October. Less than 10% of Class I recalls are associated with clinical risks that may have been discovered during premarket testing. Most recalls, the academics from Harvard University and Yale University wrote, are instead associated with postmarketing issues like manufacturing mistakes.
The two said FDA’s efforts to expand use of its Safety and Performance Based Pathway could help mitigate some premarket testing limitations, if the agency is successful in “realizing the promise of this reform.”
“Prespecifying performance criteria may help to ensure that devices are consistently evaluated on the basis of the technical or clinical specifications most critical to safety and effectiveness,” they wrote.
Shuren told MedTech Dive the pathway, which FDA has focused on developing this year in particular, presents an opportunity for a more efficient way for companies to apply for clearance.
“It can be more straightforward to demonstrate that you’ve met an objective performance criteria or semi-objective criteria, than it may be to compare yourself technologically with the predicate device,” he said. “Companies will have a better idea if, in fact, their device is substantially equivalent before they are even coming in the door.”
As of early December, the agency has released five device-specific draft guidances, but FDA does not have an estimate for how many may come out in 2020 due to the resource-intensive process to develop them, according to Shuren.
“We’re going back over the records we have from prior 510(k) submissions as well as looking at other information from other sources and that takes time given the state of our current of our current information technology databases,” Shuren said.
“In the future, hopefully we will have better IT capabilities and it will require less resources to do, but right now it is a labor-intensive undertaking and that may limit the number of technologies that can be under the program at the present time.”

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