APR 30, 2014
The FDA has proposed a new program to help patients with life-threatening or seriously debilitating illnesses gain expedited access to medical devices still in early-stage development.
The proposed Expedited Access 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. This should provide these patients with earlier access to safe and effective medical devices, according to the FDA.
“We are excited to offer a proposed program for expedited access for certain high-risk medical devices,” said Jeffrey Shuren, MD, 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 the program, a medical device must be intended to treat or diagnose a life-threatening or irreversibly-debilitating disease or condition, have acceptable data development plan that has been approved by the FDA, and present one of the following scenarios:
- No approved alternative treatment/diagnostic exists;
- The device is a breakthrough technology that provides a clinically meaningful advantage over existing technology;
- The device offers a significant, clinically meaningful advantage over existing approved alternative;
- The device’s availability is in the patient’s best interest.
The program builds on the FDA’s Innovation Pathway pilot program launched in 2011 and its expedited review programs for pharmaceuticals.
In addition to the Expedited Access Program, the FDA has published a separate draft guidance that outlines the agency’s current policy on when data can be collected after product approval and what actions are available to the FDA if approval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 post-market 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.
The FDA is seeking public comment on both the Expedited Access Program and the draft guidance.