News: FDA finalizes fast-track approval for medical devices
The FDA issues final guidance on its new fast-track approval protocol for medical devices that target life-threatening or debilitating conditions.
The FDA today issued its final guidance on a new, fast-track approval protocol for medical devices aimed at deadly or debilitating illnesses with no treatment options.
The safety watchdog's Center for Devices & Radiological Health said its Expedited Access Program allows companies with devices for life-threatening or irreversibly debilitating conditions, that would normally be subject to the stringent pre-market approval process or the de novo clearance program, to ask for fast-tracking at the agency.
part from devices addressing unmet needs, breakthrough technologies that provide "a clinically meaningful advantage over existing legally marketed technology" are also eligible for the EAP track, the FDA said. Devices that offer "significant, clinically meaningful advantages over existing legally marketed alternatives" or whose availability is in the best interest of patients are also candidates, the agency said. Breakthrough technologies can include new products and new applications for existing products, the FDA said.
"The data development plan will shift premarket data collection to the postmarket setting, to the extent appropriate, taking into account the public health benefit of these devices, while still meeting the U.S. approval standard of reasonable assurance of safety and effectiveness," CDRH director Dr. Jeffrey Shuren wrote today in a blog post. "The premarket data must be adequate to support FDA’s high standard for premarket review but can include data based on an intermediate endpoint or a surrogate endpoint reasonably likely to predict clinical benefit."
The FDA can accept a greater degree of uncertainty if it decides a device's benefits outweigh the risks, Shuren wrote, if the risk "is sufficiently balanced by other factors, including the probable benefits to having earlier access to the device."
Drug-device combinations "may raise unique scientific and regulatory challenges," according to the safety bureau, meaning that companies seeking the EAP track for those devices should enquire as early as possible about its feasibility.