New FDA Program Would Speed Up Access to Medical Devices

Megan Brooks

April 22, 2014

The US Food and Drug Administration (FDA) has proposed a new program designed to grant earlier access to high-risk medical devices intended to treat or diagnose patients with serious conditions whose needs are unmet by current technology, according to an FDA news release.

The program is called the Expedited Access Premarket Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions ("Expedited Access PMA" or "EAP").

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," the FDA said today.

Speeding the Development Process

The EAP program is not a new pathway to market but, rather, a collaborative approach to facilitate faster product development under the agency's existing regulatory authorities, the agency emphasizes.

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

To be eligible to participate in the program, the medical device must be intended to treat or diagnose a life-threatening or irreversibly debilitating disease or condition and represent 1 of the following: that no approved alternative treatment/diagnostic exists, that it is a breakthrough technology that provides a clinically meaningful advantage over existing technology, the offer of a significant, clinically meaningful advantage over existing approved alternatives, or that its availability is in the patient's best interest.

The device must also have an acceptable data development plan that has been approved by the FDA.

Under the EAP program, manufacturers will still have to provide a "reasonable assurance of safety and efficacy," the FDA said.

The FDA also published today a separate draft guidance that outlines the agency's current policy on when data can be collected after product approval and what actions are available to the FDA if approval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 postmarket data collection, are not met. The guidance includes advice on the use of surrogate or independent markers to support approval, similar to the data points used for accelerated approval of prescription drugs.

"To assure that a device is safe and effective and provide timely patient access to breakthrough devices, it's critical to get the right balance between premarket data collection and postmarket data collection," Dr. Shuren said.

The FDA is seeking public comment on both documents.

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