FDA Proposes Expedited Access Program for Medical Devices

In April, the U.S. Food and Drug Administration proposed a new program to provide earlier access to high-risk medical devices that are intended to treat or diagnose patients with serious conditions whose medical needs are unmet by current technology.

The proposed Expedited Access Premarket Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions (“Expedited Access PMA” or “EAP”) program seeks to reduce development and approval time through 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.

 In a press release, the FDA states that these features should provide patients with earlier access to safe and effective medical devices. “EAP is not a new pathway to market, but rather a collaborative approach to facilitate product development under the agency’s existing regulatory authorities. 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 release states. It would only expedite access for certain high-risk medical devices.

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:

• no approved alternative treatment/diagnostic exists, or
• represents a breakthrough technology that provides a clinically meaningful advantage over existing technology, or
• offers a significant, clinically meaningful advantage over existing approved alternatives, or
• the availability is in the patient’s best interest. 

• Have an acceptable data development plan that has been approved by the FDA.

In addition to the Expedited Access Program, the FDA published a separate draft guidance that outlines the agency’s current policy on when data can be collected after a product has been approved and what actions are available to the FDA if approval conditions, such as post-market data collection, are not met. The guidance also covers advice on the use of surrogate or independent markers to support approval, similar to the data points used for accelerated approval of prescription drugs. 

Information and the draft guidance can be found at www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm393879.htm.

Teresa McCallion, EMT-B, is the managing editor of Integrated Healthcare Delivery.