Today FDA introduced a voluntary program that will help manufacturers reduce time and money in getting certain life-saving devices to market, while still complying with FDA’s standards for assuring safety and effectiveness. Under the Expedited Access Pathway (EAP) Program, if a medical device meets specific criteria, including presenting a significant breakthrough over existing available technology, it will be put on a special approval track.
The agency released two final guidance documents with the intent of enabling “timely access” to new technologies.
“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,” writes CDRH Director Jeffrey Shuren, MD, in FDA’s blog, FDA Voice. “At the same time, delayed access may mean the difference between life and death, or may result in irreversible disability.”
The 44-page guidance document, “Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions”, reviews criteria for acceptance into the EAP program. According to the guidance document, the device must:
- Be intended to treat/diagnose a life-threatening or irreversibly debilitating disease or condition
- Meet specific criteria for addressing an unmet need
In addition, the device manufacturer must submit a Data Development Plan, which explains clinical and nonclinical data that would be collected in the premarket and postmarket phases, among other requirements.
With faster approval, some critics might argue that there won’t be enough time to gather important information. Shuren acknowledges the risk, noting “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.”
Beginning on April 15, FDA will begin accepting requests for the EAP program. One of the most important elements of the program is more frequent, and earlier, collaboration between the device manufacturer and FDA.
The other final guidance document further explains FDA’s policy on premarket and postmarket data collection during PMA review.