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 in the design of clinical studies that adequately reflect the intended use population for 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 facilitating the availability of and access to medical technologies for all populations, according to its August 5 announcement.

The agency said the goals of its discussion paper, Health Equity for Medical Devices, and request for public comments are to empower people to make informed decisions regarding their healthcare, while supporting the innovation of novel and existing technologies and reducing barriers to increased participation by diverse populations in evidence generation. 

It's asking whether clinical data can be generalizable to and representative of the intended use population identified for a particular device.

"Specifically, the discussion paper requests feedback on possible considerations that may help inform the design of a clinical study that adequately reflects the intended use population for a particular medical device," the agency said.

Public comments are due by October 4.

THE LARGER TREND

Pulse oximeters, which use light to take their measure of patients, are affected by skin tone, the medical community learned during COVID-19, and are an example of racial bias, according to Johns Hopkins School of Medicine policy experts.

Cleared by the U.S. Food and Drug Administration in the 1980s under the 510(k) review process, hundreds of racially biased pulse oximeters are based on old designs, they said in July.

An FDA spokesperson told Healthcare IT News last month that a revision to that guidance is listed on the agenda with the intent to publish in FY 2024 – which ends September 30, according to the U.S. Treasury.

In February, doctors and researchers from the University of Maryland School of Medicine, the VA Maryland Healthcare System and others voiced concern that artificial intelligence summarizing clinical data might be exempt under FDA criteria and could cause patient harm.

"As summarization tools speed closer to clinical practice, transparent development of standards for [large language model]-generated clinical summaries, paired with pragmatic clinical studies, will be critical to the safe and prudent rollout of these technologies," the researchers said.

In May, the House Energy and Commerce Health Subcommittee held a hearing on the FDA's regulation of drugs, biologics and medical devices, during which lawmakers grilled agency directors on medical device missteps 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 help to reduce barriers to achieving health equity and that help to improve health outcomes across diverse populations," the agency said in the discussion paper.

"Given the diversity of the U.S. population, medical device clinical studies should adequately represent the population that is intended to use the device so that the information generated from the study can provide an understanding of device performance across populations."

Andrea Fox is senior editor of Healthcare IT News.
Email: afox@himss.org
Healthcare IT News is a HIMSS Media publication.

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