In an effort to make medical devices available to patients with life-threatening or irreversibly debilitating conditions who lack treatment and diagnostic options faster, the FDA's new Expedited Access Program will begin next week.
Starting April 14, manufacturers of these devices that meet an unmet need can request an EAP designation.
Under this designation, a host of added benefits open up for the manufacture including, but limited to, working with senior staff of the FDA's Center for Devices and Radiological Health to create a Data Development Plan that provides predictability and leverages postmarket data collection.
"If, after careful analysis, FDA determines that some data can be collected after the device is on the market, then patients in need will benefit sooner," wrote Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health, on the FDA Voice's blog. "A few of the factors that can enter into this analysis include a low probability of serious harm, a high likelihood that postmarket surveillance can quickly identify instances of serious patient harm and a high likelihood that postmarket data collection will be completed in a timely manner."
