Building NEST: New Executive Director, CDRH's Shuren Discuss Plans

Regulatory NewsRegulatory News | 27 September 2017 |  By 

The group of stakeholders building the National Evaluation System for health Technology (NEST) outlined what’s in store for the new future as well as the direction that they want the system to go.

"NEST is about how we improve the value, use, and time and cost of using real-world data," Jeff Shuren, director of the US Food and Drug Administration’s (FDA) Center for Device and Radiological Health (CDRH), explained to attendees of AdvaMed’s MedTech conference in San Jose, California. He also told companies to get on board with NEST now because there are some private collections of real world data that are ramping up, but industry will not have a say in how those are crafted.

He also noted on Wednesday that the latest medical device user fee agreement set a deadline of the end of calendar year 2019 for there to be a viable NEST up and running.

And though the approval of Edward Lifesciences’ transcatheter aortic valve replacement is often mentioned as the sole example of RWD used in a regulatory decision, Shuren said there are others and more coming and that companies should get on board as they seek to obtain "answers more quickly and at lower costs."

Pat Shrader, VP of regulatory affairs at Medtronic, noted that initially there was a lot of industry skepticism with NEST, though she said the demonstration projects and industry’s involvement is important.

In 2016, FDA awarded a grant to the Medical Device Innovation Consortium (MDIC) to establish the NEST Coordinating Center, and Rachael Fleurence was appointed as the new executive director.

Fleurence told attendees on Monday of the 1 November deadline for submitting applications for the next round of demonstration projects. The call is targeting mature projects currently underway that have existing sources of funding for core activities, and preference is given to projects with multiple partners, including one or more device companies.

"What we need is to hear from you on questions and concerns," Fleurence said, including how best to build out NEST. "We would love to see more industry involved, particularly if you’re working for a small company."

She also explained that some of the barriers to developing NEST have been well-known for a while, including a lack of structured data, data that are siloed and stay behind firewalls and other issues that "make it hard to do high-quality research."

Also during the same session, Michelle McMurry-Heath, J&J vice president, told attendees that the European Commission is currently considering whether to adopt a unique device identifier (UDI) system that’s the same as what FDA has developed or different.

"Can you imagine going through this process twice?" she said.

Shuren also said industry should speak out on how an EU-based UDI system should be implemented.

"We don’t want to have different UDI systems out there," he said. "Folks need to step up to the plate now and ask questions and express opinions."


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