FDA aims to promote health equity for medical devices
The U.S. Food and Drug Administration’s Center for Devices and Radiological Health asks the public to consider disease burden, technology, and other factors in the design of clinical trials so that these trials adequately represent the intended population for a particular medical device.
WHY IT IS IMPORTANT
As part of CDRH’s 2022 to 2025 strategic priority: advancing health equity, the agency will
said it is committed to facilitating the availability and access to medical technologies for all populations, according to its August 5 report announcement.
According to the agency, the goals of the discussion paper, “Health Equity for Medical Devices,” and the request for public comment, are to empower people to make informed decisions about their health care, support innovation of new and existing technologies, and reduce barriers to greater participation of diverse populations in evidence generation.
The question is whether clinical data are generalizable to and representative of the intended user population of a particular device.
“The discussion paper specifically requests feedback on potential considerations that may help inform the design of a clinical trial that adequately serves the intended population for a particular medical device,” the agency said.
Public comments must be received by October 4.
THE BIGGER TREND
Pulse oximeters, which use light to measure patients’ temperatures, are affected by skin color, a phenomenon the medical community has learned during COVID-19. They are also an example of racial bias, according to policy experts at Johns Hopkins School of Medicine.
Hundreds of racially biased pulse oximeters based on old designs were cleared by the U.S. Food and Drug Administration in July under the 510(k) review process.
An FDA spokesperson said Healthcare IT News last month that a revision of that guidance is planned for publication in fiscal year 2024, which ends Sept. 30, the U.S. Treasury Department said.
In February, doctors and researchers from the University of Maryland School of Medicine, the VA Maryland Healthcare System and others raised concerns that artificial intelligence that summarizes clinical data could be exempt under FDA criteria and harm patients.
“As summarization tools become increasingly aligned with clinical practice, transparent development of standards for (large language model) generated clinical summaries, combined with pragmatic clinical studies, will be critical for the safe and prudent rollout of these technologies,” the researchers said.
In May, the House of Representatives Energy and Commerce Health Subcommittee held a hearing on the FDA’s regulation of drugs, biological products, and medical devices. During the hearing, lawmakers questioned agency directors about medical device missteps and how they would proceed with reviewing AI-enhanced clinical decision support products.
ON THE RECORD
“FDA recognizes the urgent public health need for innovative technologies that help reduce barriers to achieving health equity and contribute to better health outcomes for diverse populations,” the agency said in the discussion paper.
“Given the diversity of the U.S. population, clinical trials of medical devices should be a good representation of the population that will use the device. That way, the information generated from the trial can provide insight into the performance of the device across populations.”
Andrea Fox is Editor-in-Chief of Healthcare IT News.
Email address: afox@himss.org
Healthcare IT News is a publication of HIMSS Media.
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