The FDA will accept comments about a proposed program designed to expedite access to high-risk medical devices for patients with unmet needs.
The FDA released a draft document outlining its new Expedited Access Premarket Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions program, which is also known as Expedited Access PMA and EAP for short. The proposed structure will facilitate earlier contact between FDA staff and industry and allow more collaborative interaction over clinical and data aspects of studies used in the approval process, according to the agency.
“EAP is not a new pathway to market, but rather a collaborative approach to facilitate product development under the agency’s existing regulatory authorities,” the FDA wrote. “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.”
Eligible medical devices must be intended to treat or diagnose a life-threatening or irreversibly-debilitating disease or condition; or fill a treatment or diagnostic void; be a clinically meaningful breakthrough technology; offer a significant advantage over existing approved alternatives; or whose availability is in the patient’s best interest. Devices also must have a data development plan approved by the FDA.
The public has 90 days after publication of the draft guidance in the Federal Register to review the proposal and submit comments. The proposal is available here.