CDRH's Shuren Extols Victories of Flexible Regulatory Approach

During a State of the Union lecture, CDRH director Jeffrey Shuren highlighted early wins of FDA's shift toward postmarket surveillance, novel approaches to evidence generation, and focus on patient inputs.

Shuren discusses FDA regulatory priorities with other panelists at the TCT Conference.

CDRH's focus on its strategic priorities is already yielding fruit in the form of faster, more frequent device approvals and increased patient access to new technologies, according to Jeffrey Shuren, MD, JD, director of CDRH. Among the initial victories: an expanded indication for transcatheter aortic valve replacement (TAVR) therapy and approval of a first generation artificial pancreas.

Shuren made the comments during his FDA/CDRH State of the Union lecture in front of an audience at the FDA Town Hall Meeting held during the Transcatheter Cardiovascular Therapeutics conference in Washington, DC on October 31.  

In 2014-2015, CDRH's strategic priorities included improving the clinical trial system and finding a way to shift some premarket data collection to postmarket collection. As part of that, the Center created the Expedited Access Pathway (EAP) Program for breakthrough devices, encouraged more device sponsors to take part in early feasibility studies with the United States, and put a more flexible benefit-risk model in place.

Those moves paid off with more U.S. early feasibility studies, a large reduction in the median time it takes to receive IDE full approval, and in 2015, the highest number of IDEs approved in the first cycle in any year since 2002. One of the first devices in the early feasibility pilot program, the Angel Catheter from Bio2 Medical, received FDA 510(k) clearance in August 2016. Of 47 requests for EAP designation since the program started in April 2015, 23 requests were granted and 11 IDEs have already been received, Shuren said.

The Strategic Priorities for 2014-2015 naturally progressed in to the 2016-2017 Strategic Priorities, which include partnering with patients and creating a National Evaluation System for health Technology (NEST). 

"To truly understand the benefits-risk profile of a device, you need to study it in the wild . . . The challenge is, although that data is collected all the time, a massive inefficiency is that we can't make great use of it," Shuren said. NEST is being designed to make better use of real-world clinical data.

Ideally, NEST will be able to reduce the time and cost of gathering real-world data and making it more valuable and accessible to stakeholders, Shuren said. In September 2016, the Medical Device Innovation Consortium (MDIC) was selected to establish and operate the Coordinating Center for NEST. Shuren described NEST as using a neural network approach to optimize data sharing and answer research questions quickly: "Therefore, NEST really becomes a way of activating different kinds of networks depending upon the question that needs to be addressed."

Shuren was quick to point out that FDA is already using real-world data for the premarket and postmarket settings, such as labeling indications expansions using the Transcatheter Valve Therapy registry, use of registry data as a control for single-arm trials, and databases used to evaluate in vitro diagnostics. What's more, some companies have begun "nesting" postmarket trials and registries and have found the approach saves 40-60% on costs, he noted.

The use of real-world data has made a difference. In 2015, FDA approved the most novel devices of any year since 2003 and the agency has also been "on par" with other countries in approving early feasibility studies for transcatheter mitral valve replacement devices, Shuren said. He also pointed to the fact that while the original FDA approval of TAVR trailed Europe by more than four years, the recent expanded indication into intermediate risk patients was granted in the United States and in Europe several days apart. Edwards Lifesciences' Sapien 3 received FDA approval for the intermediate risk indication on August 18 and received CE Mark for the expansion on September 19.

"We recently approved the Medtronic 670G hybrid closed-loop system for Type 1 diabetics, what some have called first generation artificial pancreas. We're not just the first one in the U.S. This was the first one in the world," Shuren said, adding that it "came on the market three years earlier than the company originally intended to have it in."

More reliance on real-world data and prioritization of patient access has meant that the "inflection point to come to market has now changed, [it's] much more fluid," Shuren said.