FDA says real-world data, focus on software will keep pace with device innovation

Real-world patient data will serve as an integral part of the FDA’s medical device review process, speeding up the approval process to keep pace with digital and technology innovators.

The success of that approach relies on the reauthorization of the Medical Device User Fee Amendments (MDUFA) scheduled for implementation in October 2017. In a House Energy and Commerce Subcommittee on Health hearing on Tuesday, lawmakers, industry representatives and a senior FDA administrator appeared willing to move forward with draft agreement of MDUFA IV announced (PDF) last year that would bring in nearly $1 billion in user fees and push the agency's data-driven approach.

“Make no mistake about it, we’re going to get our work done, and we’ll have it done in a timely fashion,” said Subcommittee Chairman Michael Burgess, R-Texas.

Lawmakers commended Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health (CDRH), for the progress the agency has made since the last MDUFA agreement, noting that premarket approval (PMA) times have reduced 35% since 2009, while 510(k) approval times have dropped 11%.

In submitted testimony (PDF), Shuren noted that the FDA has approved more innovative devices in 2016 than in any other year in the center's history, and took one of the “biggest deregulatory actions for CDRH in decades” by backing off enforcement of lower-risk digital devices.

Digital health experts previously told FierceHealthcare that guidance was one way Scott Gottlieb, nominated earlier this month to lead FDA, could shape the agency’s approach to digital health enforcement.

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Part of the updated MDUFA agreement would include utilizing a portion of medical devices user fees to fund the National Evaluation System for health Technology (NEST), a stakeholder owned and operated system that would leverage real world data buried in EHRs and health registries to support regulatory decisions. Rather than forcing companies to conduct expensive and often time-consuming clinical trials, the FDA said using existing patient data—where appropriate—would speed the process while ensuring safety.  

“For so long we focused on protecting public health; we also have to think about promoting public health,” Shuren said. “It’s not just ensuring medical devices are safe and effective, but also that patients have timely access and we facilitate device innovation.”

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The MDUFA IV agreement would also establish a central digital health unit within the CDRH aimed at streamlining the FDA review process for software as a medical device and software inside a medical device. Through that unit, the agency would explore premarket approval pathways specifically designed specifically for that software.

“We’re looking to change the paradigm on software as a medical device to better meet the rapid innovation cycles we’re seeing in this technology,” Shuren said.

Lawmakers did not address a perplexing provision in President Donald Trump’s budget that called on the FDA to increase its user fees in fiscal year 2018 in exchange for a streamlined approval process. Experts told FierceHealthcare increased user fees could place a larger burden on smaller digital health startups seeking regulatory approval.