By: Gayle S. Putrich
April 22, 2014
WASHINGTON — The U.S. Food and Drug Administration is proposing an expedited approval for medical devices for devices aimed at the diagnosis or treatment of patients with serious conditions that would otherwise go untreated.
Introduced April 22, the “Expedited Access Premarket Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions,” or “Expedited Access PMA” would include earlier and more engaged interaction with senior-level FDA staff which the agency believes will lead to faster patient access to safe medical devices.
“We are excited to offer a proposed program for expedited access for certain high-risk medical devices,” said Dr. Jeffrey Shuren, director of the 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.”
The program builds on the FDA’s experience with expedited review programs for pharmaceuticals and would be open to devices that are intended to treat or diagnose a life-threatening or irreversibly-debilitating disease or condition for which no approved alternative treatment or diagnostic equipment exists, or for a breakthrough technology that provides a clinical advantage over existing technology or approved alternatives. Participating device manufacturers must have an acceptable data development plan that has been approved by the FDA.
According to the agency, the Expedited Access PMA is not a new pathway to market, but a collaborative approach to facilitate product development under existing regulations. While other existing device programs have focused on reducing the time for pre-market review, the new approach, if adopted, would aim to also reduce the time associated with product development.
In a separate draft guidance, the also outlined the agency’s current policy on when data can be collected after product approval and what actions are available to the FDA if approval conditions, such as post-market data collection, are not met.
Included in the guidance is advice on the use of surrogate or independent markers to support approval, similar to the data points used for accelerated approval of prescription drugs.
Both proposals are open for public comment at www.fda.gov/medicaldevices