The U.S. Food and Drug Administration is looking to expedite the approval process for medical devices that would help patients whose urgent healthcare needs aren't met by current technology.
The move follows recent criticism that FDA oversight of mHealth devices and systems would hinder innovation and threaten lives.
Announced on April 22, the "Expedited Access Premarket Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases of Conditions" – shortened to "Expedited Access PMA" or "EAP" – program would enable mHealth vendors to work more closely with FDA staff for pre-market approval. FDA officials said the program would include "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."
“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, in a 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 pre-clinical trial phase.”
To qualify for the EAP program, medical devices would have to meet certain conditions. The device must be intended to treat or diagnose a life-threatening or irreversibly deteriorating disease or condition and have an acceptable data development plan that has already been approved by the FDA. In addition, it must do one of four things: address a treatment or diagnostic method that doesn't currently exist, represent a breakthrough technology that provides a clinically meaningful advantage over existing technology, offer a significant advantage over other approved alternatives or represent the patient's best interest.
FDA officials pointed out that this program wouldn't create a new pathway to market approval, but "a collaborative approach to facilitate market development under the agency's existing regulatory authorities."
In addition to the EAP program, the FDA published a separate draft guidance that explains the agency's current policy on approval of mHealth devices. Of particular importance is the reliance on data collection to verify the product's value.
“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 the release.
The FDA is seeking public comment on both documents.