The U.S. Food and Drug Administration’s Center for Devices and Radiological Health is asking the public to consider disease burden, technology, and other factors when designing clinical studies that adequately reflect the intended users of a particular medical device.
WHY IT MATTERS
As part of CDRH’s 2022 to 2025 Strategic Priority: Advancing Health Equity, the agency said it is committed to making health technologies accessible and available to all, according to an August 5 announcement.
The agency said the goal of the discussion paper, titled Equity in Healthcare for Medical Devices and its request for public comment, is to empower people to make informed decisions about their health care, support innovation in new and existing technologies, and reduce barriers to greater participation in the evidence generation process by diverse populations.
The question is whether clinical data are generalizable and representative of the intended use population identified for a particular device.
“Specifically, the discussion paper requests feedback on considerations that may help inform the design of a clinical study that adequately reflects the intended use for a particular medical device,” the agency said.
Public comments must be submitted by October 4.
THE BIGGER TREND
Pulse oximeters, which use light to measure a patient’s blood oxygen level, are affected by skin tone and are an example of racial bias, according to policy experts at Johns Hopkins School of Medicine, something the medical community has learned about during the COVID-19 pandemic.
Hundreds of racially biased pulse oximeters approved by the U.S. Food and Drug Administration in the 1980s under the 510(k) review process were based on older designs, they said in July.
FDA spokesperson said Healthcare IT News Last month, a revision to that guidance was put on the agenda with the aim of being released in fiscal year 2024 — which ends September 30, according to the U.S. Treasury Department.
In February, doctors and researchers from the University of Maryland School of Medicine, the VA Maryland Health Care System, and others voiced concerns that artificial intelligence summarizing clinical data may be exempt from FDA standards and could harm patients.
“As summary tools move closer to clinical practice, the transparent development of standards for [large language model]- The clinical summaries generated, combined with real-world clinical studies, will be critical to the safe and prudent deployment of these technologies,” the researchers said.
In May, the House Energy and Commerce Subcommittee on Healthcare held a hearing on FDA regulation of drugs, biologics, and medical devices, where lawmakers grilled agency executives about medical device-related mistakes and how they would keep up with reviewing AI-enhanced clinical decision support products.
ON THE RECORD
“FDA recognizes the urgent public health need for innovative technologies that reduce barriers to achieving health equity and help improve health outcomes for diverse populations,” the agency said in the discussion paper.
“Because the U.S. population is diverse, clinical studies of medical devices must be fully representative of the population intended to use the device so that information obtained from the study can help better understand device performance across populations.”
Andrea Fox is senior editor of Healthcare IT News.
Email: [email protected]
Healthcare IT News is a publication of HIMSS Media.
The HIMSS Healthcare AI Forum is scheduled for September 5-6 in Boston. Learn more and register.
