With a focus on how the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) can further use real-world evidence to inform its decision making, the center is considering "progressive" approvals whereby if a device comes to market in the EU before the US, it could also come to market in the US as long as additional postmarket data is submitted.
Jeff Shuren, director of CDRH, speaking by teleconference at the MedCon conference in Cincinnati on Wednesday told attendees that the progressive approval pathway could apply to certain breakthrough devices, though in order for the devices to stay on the US market, they would need to meet certain US standards. Such a pathway would be implemented alongside the expedited access pathway.
Shuren also noted the significant progress made by CDRH under the third iteration of the Medical Device User Fee Amendments (MDUFA), noting a massive four-fold increase in the number of novel device approvals from 2009 to 2016, though he also cautioned that he does not expect that kind of progress to continue at such a fast pace.
The median time to FDA approval of a device company’s clinical trial application has also fallen dramatically from 442 days in 2011 to just 30 days in 2016.
Increased patient engagement and an increased use of real-world evidence on the pre-market and post-market fronts are also top priorities for CDRH. Shuren highlighted some examples of pre-market data used to support approvals.
And under the next iteration of MDUFA, which likely will take effect 1 October, the development of FDA’s National Evaluation System for health Technology (NEST) will continue, with the goal of creating a viable system by the end of 2019.
Currently, FDA is working with the Medical Device Innovation Consortium (MDIC) and the consulting firm Deloitte to do a landscape analysis on real world data to help CDRH hone in on where to conduct demonstration projects. MDIC also recently selected Rachael Fleurence, PhD to serve as the NEST coordinating center’s first executive director.
With a nod to the further international convergence of device regulations, Shuren pointed to the work of the International Medical Device Regulators Forum, which he said can better harmonize device registries and the collection of data internationally.
Also under the next MDUFA, Angela Kreuger, acting deputy director for engineering and science review at CDRH’s Office of Device Evaluation (ODE), explained to attendees some the new goals set for pre-submission requests and de novo submissions.
On the de novo submissions, Kreuger noted that MDUFA IV ramps up from 50% of submissions being reviewed within 150 days in FY 2018 to 70% in FY 2022, which will be a considerable shift as the agency’s current performance is about 40% in 150 days.
A question from the audience asked Kreuger why the percentage of pre-market approval applications CDRH declines to accept has gone down from about 70% to 20% in recent years, though one out of five is still a high number. She explained that some of those issues with applications are related to not being up to speed on certain guidances, but also some fundamental issues, particularly for submissions from outside the US, with some not entirely in English or not properly organized.