FDA Proposes Expedited Medical Device Access Program

The agency proposes a new expedited access program for medical devices for patients whose conditions are urgent and serious.

The FDA has proposed a new, expedited access program for medical devices that would give patients with serious conditions earlier access to high-risk medical devices. The proposed program—the Expedited Access Premarket Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions (EAP)—is designed for patients whose needs are unmet by current technology, the FDA reports.

The program "features earlier and more interactive engagement with FDA staff—including  the involvement of senior management and a collaboratively developed plan for collecting the scientific and clinical data to support approval—features that, taken together, should provide these patients with earlier access to safe and effective medical devices," according to FDA.

To be eligible for participation in the program, a medical device must be intended to treat or diagnose a life-threatening or irreversibly debilitating disease, have an acceptable data development plan, and represent one of the following:

     1. No approved alternative treatment/diagnostic exists, or
     2. A breakthrough technology that provides a clinically meaningful advantage over existing technology, or 
     3. Offers a significant, clinically meaningful advantage over existing approved alternatives, or 
     4. Availability is in the patient's best interest  

"We are excited to offer a proposed program for expedited access for certain high-risk medical devices," said Dr. Jeffrey Shuren, M.D., director of FDA's Center for Devices and Radiological Health. "The program allows manufacturers to engage early and often with the agency. We expect most devices that enter this program will be in the pre-clinical trial phase."

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