The U.S. Food and Drug Administration has 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 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.
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.
"We are excited to offer a proposed program for expedited access for certain high-risk medical devices," said Jeffrey Shuren, M.D., 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."
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
- a breakthrough technology that provides a clinically meaningful advantage over existing technology, or
- offers a significant, clinically meaningful advantage over existing approved alternatives, or
- availability is in the patient's best interest
- Have an acceptable data development plan that has been approved by the FDA
The EAP builds on the Innovation Pathway pilot, which the FDA launched in 2011, and the FDA's experience with expedited review programs for pharmaceuticals, including Accelerated Approval and Breakthrough Therapies. When utilizing the EAP program, the FDA will continue to apply the current approval standard of demonstrating a reasonable assurance of safety and efficacy.
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 product approval and what actions are available to the FDA if approval conditions, such as postmarket 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.
"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," said Dr. Shuren.
The FDA seeks public comment on both documents.
- Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions - Draft Guidance for Industry and FDA Staff
- Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval - Draft Guidance for Industry and FDA Staff