The U.S. Food and Drug Administration has proposed a program that would allow earlier access to high-risk medical devices to treat or diagnose patients with serious conditions whose needs are currently unmet.
The Expedited Access Premarket Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions program, would involve more engagement with FDA staff to collaboratively collect appropriate data to support product approval, expediting the timeline for patients to access such devices, according to an FDA news release.
Unlike other EAPs that focus on expediting premarket review of a device, this particular program is aimed toward reducing the time products are spent in development.
"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," said Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health, in the news release.
The FDA has issued a draft guidance on this EPA. It is open for comments for the next 90 days.
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