The work at the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on advanced continuous learning for regulatory processes is informing agency-wide efforts.
FDA principal deputy commissioner Amy Abernethy touched on how CDRH projects and other initiatives leverage the continuous learning approach during a Wednesday keynote discussion at AcademyHealth’s Health Datapalooza 2019 in Washington, D.C.
In an interview with Focus
, Abernethy explained how continuous learning is key for CDRH to keep pace with the evolving nature of medical devices and technologies. She noted CDRH reviewers are working to ensure that their proficiency with a new product continues to grow after it enters the market, pointing to the National Evaluation System for health Technology (NEST) as a driver of these continuous learning efforts.
NEST is intended to be a major enabler of continuous learning within CDRH. Known as a real-world evidence (RWE) innovation safety net, NEST is now accepting requests for use of its data network. The specifics around how this will continue to inform regulatory decision-making and market surveillance are being fleshed out. The challenges devices pose are unique compared to other products.
Abernethy noted that other centers within FDA, including the Center for Drug and Evaluation and Research (CDER), as well as the Center for Biologics Evaluation and Research (CBER), have historically been more well-established than CDRH and other FDA-regulated medical products do not undergo near-constant changes.
FDA launched an RWE program last December in conjunction with the release of its RWE framework
on priorities in the drug space. FDA Oncology Center of Excellence associate director Sean Khozin, last month, offered a few details on guidances that will be issued
under the RWE framework for clarifications around using real-world data sources, such as electronic health records, mobile technologies and registries. In 2017, FDA finalized guidance
on using RWE for device regulatory decisions.
The continuous learning CDRH is fostering, however, has informed RWE efforts across the agency’s centers and offices. CDRH was quick to realize the need to harness such an approach or face increasing challenges with a cutoff in available product data, Abernethy noted. Others followed. Yet CDRH’s continuous learning approach is widely applicable and helping to shape the work across FDA, she said.
"CDRH really has been taking the lead around RWE," Abernethy said. It provides "the microcosm of how we think about using data in a continuous fashion to continuously monitor how a medical product is performing" and a "forward looking view of where this whole space is going because it is uniquely set up to be able to do this work." She further noted the unique position CDRH has for this work relates not only to how devices evolve, but also because data from devices are almost always naturally instrumentation data and are readily codified.