Print“The program allows manufacturers to engage early and often with the agency. We expect most devices that enter this program will be in the preclinical trial phase, says Jeffrey Shuren.”
The U.S. Food and Drug Administration has proposed a new program to speed access to 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 program, also called “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.
The idea is similar the process the agency uses to speed access to innovative drugs that address serious unmet medical needs such as Fast Track and Breakthrough Therapy designations. Policymakers, patient advocacy groups, and industry have criticized the agency’s medical device approval process as being slow, delaying patient access to new products.
The FDA says 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,” says Jeffrey Shuren, 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 preclinical 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. It must also meet one of four conditions: no approved alternative treatment or diagnostic exists; a breakthrough technology that provides a clinically meaningful advantage over existing technology, offers a significant, clinically meaningful advantage over existing approved alternatives; or availability is in the patient’s best interest. It must also have an acceptable data development plan that has been approved by the FDA.
The EAP builds on the Innovation Pathway pilot, launched by FDA in 2011, and the FDA’s experience with expedited review programs for pharmaceuticals, including Accelerated Approval and Breakthrough Therapies. FDA’s current approval standard of demonstrating a reasonable assurance of safety and efficacy will continue to be applied under the EAP.
The FDA also 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,” says Shuren.
The FDA is seeking public comment on both documents.
April 25, 2014
http://www.burrillreport.com/article-fda_proposes_early_access_pathway_for_breakthrough_medical_devices_.html
