FDA claim software assessing risk of sepsis and stroke must be categorized as a medical device

by | Oct 8, 2022 | Digital Health

According to a final guidance released by the Food and Drug Administration on September 28, some forms of risk-scoring instruments will be subject to medical device regulation. The 21st Century Cures Act exempts many of these software tools from FDA regulation, provided that the healthcare provider can independently review the recommendations’ justification and does not rely on them when making a diagnosis or treatment choice. Some device manufacturers welcomed the rules’ clarification, despite their warnings that it might delay the release of their products. While some medical device companies favored the changes and claimed they gave the FDA’s thinking greater clarity, others believed the guidance went beyond what Congress had intended.

The recommendations apply to clinical decision support software, a large class of software tools that can aid doctors and other healthcare professionals in the early diagnosis of illnesses and the generation of warnings when a patient’s status changes. For instance, software employed by Apple and Fitbit smartwatches that analyzes electrocardiogram (ECG) data to identify arrhythmias is subject to medical device regulations. The same is true for software used by radiologists to individuals classified as triage patients and assess potential pulmonary embolism cases, or for software that analyzes images to distinguish between ischemic and hemorrhagic stroke. The FDA stated in the advice that some types of prediction tools, which previously fell into a murky area, should now be regulated as medical devices. This is the clearly the most significant policy change. The government provided a software application that analyzes patient data to find signs of stroke or infection and then creates an alarm to alert a healthcare provider. Many of these risk-scoring instruments are already in use with both Epic Systems and Cerner, manufacturers of electronic health records, having created sepsis surveillance tools to find the fatal condition early on in patients’ conditions. The products are not presently FDA-approved, and a Michigan Medicine study from the previous year found that Epic’s tool was less effective than claimed. The recommendations coincide with a wider debate about how bias in medical technology may impact patient care. Recent research has demonstrated that patients with darker skin experience an overestimation of blood oxygen levels by pulse oximeters. Researchers at Sutter Health recently discovered that the error caused Black patients with COVID-19 to receive supplemental oxygen treatment hours later than expected.

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