Jeffrey Shuren, M.D., J.D.
We know that patients with life-threatening or irreversibly debilitating conditions lack treatment and diagnostic options. For these patients, earlier access to promising new devices is critically important. At the same time, delayed access may mean the difference between life and death, or may result in irreversible disability.
In weighing the benefits and risks of new technologies for these patients, we understand the need to place greater weight on the benefit of earlier access, and to also account for the risks of delayed access. Thats why weve developed theExpedited Access Program (EAP): to speed qualifying devices to patients with life-threatening or irreversibly debilitating conditions without compromising FDAs high standards for safety and effectiveness.
Under this voluntary program, sponsors of devices for life-threatening or irreversibly debilitating conditions that meet an unmet need can request an EAP designation. Also under this program, CDRH staff- including senior management work collaboratively with developers of such devices earlier and more often. These efforts include the creation of a Data Development Plan that provides predictability and leverages postmarket data collection. 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. Starting April 15th, this program will be up and running and we will begin to accept requests for EAP designation.