Blog Tag: Expedited Access Program
Tel Aviv-based MedyMatch Technology recently announced it has received Expedited Access Pathway (EAP) designation from the FDA for its intracranial hemorrahage (ICH) detection software medical device.
According to Gene Saragnese, Chairman & CEO of MedyMatch, the platform is a “first-in-class hemorrhage detection tool.” The MedyMatch device utilizes artificial intelligence and deep learning technologies to analyze non-contrast head CT images for signs of ICH. Further implementations of the MedyMatch deep vision platform include diagnosis and monitoring of acute and chronic diseases based on concurrent analysis of imaging data and other patient data. Vice President of Clinical, Regulatory, and Quality Affairs, Dr. Joshua Schulman, said:
This designation is a recognition of both the need for new assessment tools for intracranial hemorrhage and an affirmation of MedyMatch’s technical approach to assisting clinicians to need to make time-sensitive yet accurate decisions in emergency settings.
The EAP Program, intended to speed approval of certain medical devices, generally includes priority review, more interactive review, and senior management involvement. EAP designation can be awarded for devices that address unmet needs for treatment or diagnosis of life-threatening or irreversibly debilitating conditions. It is said to be expected that EAP designated devices will be transitioned to the new Breakthrough Devices program established under the 21st Century Cures Act of 2016.
A 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.
On April 15th, the U.S. Food and Drug Administration (FDA) began its Expedited Access Program (EAP), which is designed to get certain medical devices to market sooner. Under the EAP program, device sponsors collaborate early with Center for Devices and Radiological Health (CDRH) staff to put together a Data Development Plan with the agency.
Jeffrey Shuren, director of the CDRH, states that the EAP is a way “to speed qualifying devices to patients with life-threatening or irreversibly debilitating conditions without compromising FDA’s high standards for safety and effectiveness.” Shuren goes on to say that “Under the EAP, FDA may accept a greater degree of uncertainty if it is sufficiently balanced by other factors, including the probable benefits to having earlier access to the device.”
To participate in EAP, a device sponsor must submit to the FDA a request for EAP designation. Factors the FDA considers when making benefit-risk determinations for devices subject to premarket approval applications (PMA) are discussed here.
To receive EAP designation, a device must meet three criteria:
(1) the device is intended to treat or diagnose a life-threatening or irreversibly debilitating disease or condition;
(2) the device meets at least one of the following criteria: (i) no appropriate alternative treatment or means of diagnosis exists, (ii) the device represents a breakthrough technology that provides a clinically meaningful advantage over existing legally marketed technology, (iii) the device offers significant, clinically meaningful advantages over existing legally marketed alternatives, or (iv) the availability of the device is in the best interest of patients; and
(3) the sponsor submits an acceptable draft Data Development Plan.