On April 15th, the U.S. Food and Drug Administration (FDA) began its Expedited Access Program (EAP), which is designed to get certain medical devices to market sooner. Under the EAP program, device sponsors collaborate early with Center for Devices and Radiological Health (CDRH) staff to put together a Data Development Plan with the agency.
Jeffrey Shuren, director of the CDRH, states that the EAP is a way “to speed qualifying devices to patients with life-threatening or irreversibly debilitating conditions without compromising FDA’s high standards for safety and effectiveness.” Shuren goes on to say that “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.”
To participate in EAP, a device sponsor must submit to the FDA a request for EAP designation. Factors the FDA considers when making benefit-risk determinations for devices subject to premarket approval applications (PMA) are discussed here.
To receive EAP designation, a device must meet three criteria:
- the device is intended to treat or diagnose a life-threatening or irreversibly debilitating disease or condition;
- the device meets at least one of the following criteria: (i) no appropriate alternative treatment or means of diagnosis exists, (ii) the device represents a breakthrough technology that provides a clinically meaningful advantage over existing legally marketed technology, (iii) the device offers significant, clinically meaningful advantages over existing legally marketed alternatives, or (iv) the availability of the device is in the best interest of patients; and
- the sponsor submits an acceptable draft Data Development Plan.