Almost a year after its proposal, the FDA finalized plans for an accelerated review program for critical medical devices, and said it will begin accepting applications to participate in the new pathway on April 15.
The program applies to devices that "demonstrate the potential to address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions." Examples include of previous devices that would meet the condition include the first drug-coated balloon catheter to treat vascular disease.
To be accepted into the program, the device must treat a condition or diagnose a condition for which no appropriate means of diagnosis exists, provide a clinically meaningful advantage over existing technologies, or be in the best interest of patients, The FDA says.
The final guidance outlines ways in which the FDA will assist those devices get to market faster.
Increased access to FDA resources will help the devices get to market faster by leapfrogging other candidates in the queue. For example, FDA says it will involve more senior management in the approval of EAP devices and may assign the application a case manager.
In addition, the clinical data requirements will be reduced through the use of clinical or surrogate endpoints that are easier and faster to measure than traditional clinical endpoints.
Another is increased reliance on post-market data at the expense of requiring fewer time-consuming trials to create premarket data. "In order to help patients have more timely access to these medical devices, the FDA may accept less certainty regarding the benefit-risk profile of EAP devices subject to a PMA at the time of premarket approval and approve an EAP Device as long as the data still support a reasonable assurance of safety and effectiveness," the agency says.
The FDA expounded on that theme with the concurrent finalization of a related guidance "Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval." Note that this guidance applies to all devices that the FDA regulates prior to commercialization, though it is especially important for those in the EAP program.
Indeed the creation of the EAP program means the agency is moving toward its recent points of emphasis when it comes to regulating devices, namely speed and increased reliance of postmarket data. That would bring it more into line with its European counterpart, which regulatory approves critical devices years before the FDA.
During her farewell speech in March, now-retired FDA commissioner Margaret Hamburg boldly asserted that the agency approves drugs faster than any other in the world, but she did not make that claim for medical devices. Instead she said," We need to continue to look at how we regulate the world of devices because it is getting increasingly complex on one end, and then there's a whole set of other devices that really don't need much attention. This is an area where I don't think that the U.S. has gotten it completely right. I don't know that the European Union has gotten it completely right. It's an area that we need to continue to learn more about."
After the release of last year's draft guidance, AdvaMed said the proposal didn't go far enough.
The industry association was more pleased this time around, and referenced its plan to expand upon the EAP in the congressional 21 Century Cures initiative: "We commend the agency for its efforts to explore supplementary review pathways to provide more timely patient access to new technologies for life-threatening or irreversibly debilitating diseases or conditions that addresses an unmet medical need. As part of its Innovation Agenda, AdvaMed has proposed a new breakthrough pathway which builds upon FDA's EAP and would provide for transitional Medicare and Medicaid coverage for products designated and approved by FDA as 'breakthrough.'"
At the annual AdvaMed conference held in the fall, industry executives said they were seeking to expand the distinction for devices that are eligible for the accelerated pathway, but the admissions criteria in the final guidance is essentially unchanged from the draft version.