The US Food and Drug Administration (FDA) updated its medical device safety action plan on Tuesday with “an important and ambitious new goal” and explained the path forward for its planned nationwide device surveillance system.
The new goal to propel the safety action plan—released
in April—is centered around ensuring that the agency is “consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices,” FDA Commissioner Scott Gottlieb and Center for Devices and Radiological Health (CDRH) Director Jeff Shuren said in the statement.
The agency prioritized regulatory reforms to shift away from a passive approach toward an active surveillance system as it has come under increasing pressure to reform its postmarket oversight approach. A contentious debate emerged over the course of this journey about whether additional FDA authority is needed. The areas for which new oversight is needed remain unclear, but the updates indicate FDA is seeking to impose additional postmarket safety requirements on devices cleared via 510(k) submissions.
Yet “delivering on the goal to be first in the world to consistently identify and act on medical device safety signals will rest in part” on whether the agency is able to “fully leverage” the intended benefits of the currently under-developed National Evaluation System for health Technology (NEST) and resolve the funding issues which could hamper its success, according to Gottlieb and Shuren.
The vision for the FDA-funded National Evaluation System for health Technology Coordinating Center (NESTcc) is to establish an active surveillance system based on robust real-world evidence (RWE) and was considered to be challenging from the get go among both agency staff and industry stakeholders, despite the steady flow of cash that has been going into this work since $3 million was granted to the Medical Device Innovation Consortium in 2016 seed funding for NEST.
FDA saw a need to dip into internal agency funding for the additional $3 million in funding that was allocated to the NESTcc in September, agency spokesperson Deborah Kotz told Focus
. This was in addition to the annual portion of the $30 million in funding granted
under the latest reauthorization of the Medical Device User Fee Amendments
to develop NEST over five years.
“This new funding for NEST, which was provided in addition to the annual funding allocated by the latest user fee agreement, will allow us to continue supporting demonstration projects...for building out active surveillance capabilities,” Gottlieb and Shuren argued. NESTcc announced
earlier this month it has selected a total of eight RWE test cases for its first round of projects.
Current challenges in securing funding date back to the inception of the idea for the system, NESTcc Chair Michelle McMurry-Heath previously told Focus
. McMurry-Heath, who also serves as the Johnson & Johnson’s worldwide VP of regulatory and clinical affairs and global head of evidence generation, was under CDRH’s employment when a regulatory science program led to the conclusion that lack of investments has hindered firms’ ability to experiment with novel technologies.
Several moving parts underpin the funding problem, including the road to a nationwide unique device identification (UDI) system being more fraught with implementation issues at the manufacturer level than previously anticipated—prompting FDA to issue various extensions on UDI compliance deadlines—and ensuring real-world data can be used as RWE to support regulatory decision-making. These form part of the larger efforts to shift away from not just a passive to an active surveillance system, but also from greater use of pre- to postmarket data.
Gottlieb and Shuren argued use of RWE is among the “core pillars” of the medical device safety action plan. But the collectively charted course for implementing the new system nationwide is banking on whether NESTcc will be able to serve as a mechanism for agency officials to obtain a more holistic view of a total product lifecycle and as an RWE safety net for product developers.
The goals have proven to be uniquely challenging. The “rapid built-out” of NEST for which FDA is investing new resources will require “considerably more funding to fully meet its tremendous potential,” Gottlieb and Shuren said. “Funding is the principal barrier to establishing this system.”
$46 million was requested under the president’s budget for fiscal year 2019 in support of NEST’s development and related postmarket studies to tackle device-specific safety concerns. “The $46 million is the amount needed for FY19," Kotz confirmed with Focus
. "If we don't get the funding, we won't be able to fully implement the system," she added.
The agency has already seen improvements in manufacturers’ readiness in submitting clinical evidence and answering postmarket questions that would have been difficult to address in the past, according to Gottlieb and Shuren. This speaks to the desire to continue full steam ahead despite remaining barriers, but the observed new industry behavior is merely an initial result of increased awareness in leveraging data sources as NESTcc has yet to become fully operational.
Shuren—at the October annual meeting of the system that inspired NEST, MDEpiNet—offered
his view on how success of NESTcc version 1.0 will be determined in 2019, such as broad applicability and whether it can provide answers on RWE and payer-related questions. CDRH is also strengthening coordinated registry networks (CRN) hosted under MDEpiNet as these are among the NESTcc data partners. It targeted part of the September $3 million in NESTcc funding to launch projects around using claims data and pilot the use of electronic health records to study urogynecologic mesh as part of its work on the Women’s Health Technologies CRN, Gottlieb and Shuren said.