FDA’s Expedited Access Program: A Year in Review

FDA LogoA new blog post by The Food and Drug Administration (FDA) published earlier this month provides an update regarding the implementation of the year-old Expedited Access Pathway (EAP) program, which was created in April 2015 by the FDA’s Center for Devices and Radiological Health (CDRH).

The EAP’s goal is to help new breakthrough technologies undergo pre-market evaluation more quickly than traditional regulatory pathways, as previously reported on the KnobbeMedical blog. While the products in the EAP program are still required to undergo the costly and time-consuming premarket approval processes, this voluntary program potentially provides more options to patients afflicted with life-threatening or irreversibly debilitating diseases.

According to the recent update, the FDA has granted EAP designation to 17 of 29 requests made for the program, and decisions were typically made within 30 days. Once a device has been accepted into the EAP, the FDA “maintains a high level of interaction with sponsors and provides advice on efficient device development.”

The accepted requests have encompassed a spectrum of technologies including devices relating to the heart, brain, or kidneys. Additionally, the device manufacturers involved in the program have included both small start-up companies and large corporations.

In the past year, the FDA has also observed particular entities that may especially benefit from the EAP:

As the program has grown the past year, we’ve learned that companies who benefit most from this program are those that have a preliminary proof of principle for how their device works, but haven’t undertaken formal studies to support future submissions to FDA. For these companies, discussing their Data Development Plan with the FDA and agreeing on a roadmap to their marketing application and beyond is an important part of a successful review.

During these reviews, the FDA has stated that they carefully balance the potential risks and benefits of the new device against the risks of delaying a new therapy to patients. A decision may then be made by the FDA to accept more initial uncertainty for devices in the EAP program so that important technology can reach patients sooner. Once that device is on the market, the FDA and the program participant continue to collect additional data to address any potential uncertainty regarding the device’s safety and effectiveness.

As the EAP enters its second year, its successes will continue to be evaluated.

Albert Sueiras
Albert Sueiras is an associate in the Orange County office. Mr. Sueiras received his bachelor's degree in Biomedical Engineering, cum laude, from the University of Miami and also received his master's degree in Biomedical Engineering, cum laude, from the University of Florida. He received his J.D. from the University of Florida Levin College of Law, where he was a member of Phi Delta Phi. During law school, Mr. Sueiras externed at the United States Patent and Trademark Office within Art Unit 3733, focusing on patent examination of orthopedic surgical instrumentation. Mr. Sueiras also participated in a patent prosecution externship at Banyan Biomarkers, Inc. in Alachua, Florida, a firm specializing in the discovery of biomarkers for traumatic brain injury and neurotoxicity. Mr. Sueiras worked as a summer associate at the firm in 2015 and joined the firm in 2016.
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