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FDA launches Expedited Access Pathway program for devices
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The FDA has introduced its Expedited Access Pathway Program, a voluntary program designed to reduce the time from development to marketing decision for certain lifesaving medical devices, the agency said on its website.
Under the program, sponsors of devices to treat life-threatening or debilitating conditions that address an unmet need can request an Expedited Access Pathway (EAP) designation. The FDA’s Center for Devices and Radiological Health (CDRH) will work with developers of these devices to decrease the time and cost to bring these devices to the market. The CDRH will collaborate with device manufacturers to establish a Data Development Plan, which will transfer premarket data collection to the postmarket setting, where appropriate, while still meeting the FDA’s approval standard of reasonable assurance of safety and effectiveness.
“Under the EAP, FDA may accept a greater degree of uncertainty if it is sufficiently balanced by other factors, including the probable benefits to having earlier access to the device,” Jeffrey Shuren, MD, director of the CDRH, wrote in a blog post. “If, after careful analysis, FDA determines that some data can be collected after the device is on the market, patients in need will benefit sooner.”
This decision may be influenced by factors such as low likelihood of serious harm from the device, high probability that instances of serious patient harm will be quickly identified in postmarket surveillance, and high probability that postmarket data collection will be completed expeditiously.
The FDA will begin to consider requests for EAP designation starting April 15.
A device may be eligible for an EAP designation if it is designed for the treatment or diagnosis of a life-threatening or permanently disabling condition.
In addition, it must meet at least one of the following criteria:
- There is no appropriate alternative treatment or diagnostic device.
- The device embodies a breakthrough technology offering a clinically significant benefit over currently existing, legally marketed technology.
- The device provides substantial and clinically meaningful advantages over current, legally marketed devices.
- Access to the device is in patients’ best interest.
The device sponsor must also submit an acceptable Data Development Plan, FDA said on its website.
The FDA suggests that device sponsors interested in an EAP begin the process of making the request early in the development of the device. Sponsors should request EAP designation before initiating an investigational device exemption (IDE) pivotal study, to ensure that the data being collected are suitable for inclusion in the device’s marketing submission.
Device sponsors interested in requesting an EAP should submit a pre-sub by following the directions provided here: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM313794.pdf
Products granted EAP designation will be given priority review by the FDA, Shuren wrote in the blog post.
“This feature, combined with the other elements of the EAP program, will reduce the time it takes to develop important new medical devices for patients with unmet medical needs, and it will do so without ever lowering our standards,” Shuren wrote.