FDA’s process for regulating medical devices has come under fire in recent years for being both too cautious and too thorough. With the launch of a new program, the agency is acknowledging that there is some truth in the former argument.
“In weighing the benefits and risks of new technologies for [patients with life-threatening or irreversibly debilitating conditions], we understand the need to place greater weight on the benefit of earlier access, and to also account for the risks of delayed access,” writes CDRH director Jeffrey Shuren, MD on the FDA website.
To address the problem, the agency is developing an Expedited Access Program (EAP), which is designed to accelerate the path to market for devices intended to treat the sickest patients. The program will launch on April 15 and would redefine how the industry approaches benefit-risk analysis for some products. The agency, however, stresses that the program does not mean the agency is lowering its standards for evaluating safety and efficacy; it is merely a way to expedite the approval of qualifying products.
The agency states that the EAP does not constitute a new pathway to market. Instead, it is a new approach intended to both speed premarket review and product development timelines.
To qualify for the EAP, a device maker must request special designation.
The product in question must be:
used to treat an ailment for which there is no approved alternative treatment or diagnostic product;
a device representing a considerable clinical advantage over existing technology or existing approved alternatives; or if availabilty of the technology is deemed to be in the patients’ best interest. If a product qualifies for the program, the agency will commit to working with the device maker earlier and more often than it ordinarily would.
The program would give medical device firms more responsibility in tracking devices after they have hit the market, while streamlining the requirements for premarket data collection. “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,” Shuren explains in his message.
The program is an outgrowth of the agency’s Innovation Pathway, which was launched in 2011.
A new guidance document, titled "Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions," provides more details about the program.