The US Food and Drug Administration (FDA) has issued an immediately-in-effect guidance that allows manufacturers of certain FDA-cleared non-invasive, vital-sign-measuring devices to expand their use so that health care providers can use them to monitor patients remotely.
The devices include those that measure or detect common physiological parameters such as body temperature, respiratory rate, heart rate and blood pressure. According to the FDA, the policy reflects its “commitment to ease burdens on health care providers and facilities as they face COVID-19”.
Among those listed are electrocardiographs (ECG) and cardiac monitors, as well as electrocardiograph software for over-the-counter use and non-invasive blood pressure devices.
For the duration of the public health emergency, states the FDA, it “does not intend to object to modifications to the FDA-cleared indications, claims, or functionality of the subject devices without prior submission of a premarket notification where the modification does not create an undue risk in light of the public health emergency”.
The guidance is being implemented without prior public comment because the FDA says it has determined that it is not feasible or appropriate. The FDA explains that it is intended to help expand the availability and capability of non-invasive remote monitoring devices to facilitate patient monitoring while reducing patient and healthcare provider contact and exposure to COVID-19 during the pandemic. It will only remain in effect for the duration of the public health emergency related to COVID-19 declared by the US Department of Health and Human Services (HHS).
