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Regulatory News | 31 May 2016 | By Zachary Brennan
A little more than a year since the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) put the finishing touches on a new expedited review process for potentially life-saving medical devices and the agency has accepted almost 60% of the applications of those looking to be a part of the new program.
Over the past year, CDRH has made 29 decisions on requests for designation into its voluntary Expedited Access Pathway (EAP) program, and of those, 17 have been accepted and 12 denied. Decisions on such requests were also made quickly, typically within 30 days, FDA says.
The EAP is a voluntary program for certain devices that could potentially address unmet medical needs for life threatening or irreversibly debilitating diseases.
Such devices are subject to premarket approval applications (PMA) or are eligible for de novo requests, and under the program, detailed in guidance finalized in April 2015, FDA works with device sponsors to try to reduce the time and cost from development to marketing, without changing its approval standards on safety and effectiveness, or the standard of valid scientific evidence.
Components of the program include priority review, more interactive review, senior management involvement and assignment of a case manager, though the extent to which FDA provides these features depends on the availability of resources.
In some cases, FDA acknowledges that it may be helpful to accept more initial uncertainty for devices in the EAP so that patients can gain access to a device more quickly while this uncertainty can be further addressed with the collection of postmarket data.
So far, EAP designation requests, which have been open since 15 April 2015, have included devices to help treat heart, brain and kidney diseases and conditions, and the devices are manufactured by both small start-ups and large corporations.
“We expect that our resources and focus on these promising technologies under the EAP program will allow them to be evaluated and enter the market more quickly, therefore providing options to the patients who need them most,” Erin Cutts, policy lead for the Office of Device Evaluation, and Jeffrey Shuren, CDRH Director, wrote in a blog post on Tuesday.
And for device companies looking to get an EAP designation in the program’s second year, FDA says projects should meet certain qualification criteria, including that the device treats or diagnoses a life threatening or irreversible disease or condition; that the device addresses an unmet need, which is usually shown by comparing the device to other available options; and that the company has a “Data Development Plan” outlining what will be included in future submissions to FDA to prevent confusion and delays later in the review process.
“As the program has grown in 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,” Cutts and Shuren write.
Celebrating a Year of the Expedited Access Pathway Program for Medical Devices
Tags: expedited device approvals, EAP, breakthrough devices