FDA floats expedited approval for unmet needs

The FDA today proposed a new regulatory option for high-risk medical devices that address unmet needs, aiming to speed access to the devices for patients.

The FDA said the "Expedited Access Pre-market Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions" would feature "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."

"We are excited to offer a proposed program for expedited access for certain high-risk medical devices," Dr. Jeffrey Shuren, director of the FDA’s Center for Devices & Radiological Health, said in prepared remarks. "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 FDA said the expedited PMA program is not a new path to market, but rather "a collaborative approach to facilitate product development" under existing rules.

"While other existing device programs have focused on reducing the time for the premarket review, EAP also seeks to reduce the time associated with product development," the watchdog agency said.

"To be eligible for participation in the program, the medical device must: 

• Be intended to treat or diagnose a life-threatening or irreversibly-debilitating disease or condition
• 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
• Have an acceptable data development plan that has been approved by the FDA," according to the release.

The FDA also issued new guidance on post-approval studies "and what actions are available to the FDA if approval conditions, such as post-market data collection, are not met," according to the release.

"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 pre-market data collection and post-market data collection," Shuren said in a statement.