In response to the COVID-19 outbreak in the United States, the FDA has issued a new policy that allows manufacturers of certain FDA-cleared noninvasive, patient monitoring devices to expand their use so that healthcare providers can use them to monitor patients remotely.
The devices include those that measure body temperature, respiratory rate, heart rate and blood pressure:
|Device Type Classification||Regulation||Product Code|
|Clinical electronic thermometer||21 CFR 880.2910||FLL|
|Electrocardiograph (ECG)||21 CFR 870.2340||DPS|
|Cardiac monitor||21 CFR 870.2300||DRT, MWI, MSX, PLB|
|Electrocardiograph software for over-the-counter use||21 CFR 870.2345||QDA|
|Pulse Oximetry (SpO2)||21 CFR 870.2700||DQA|
|Non-invasive Blood Pressure (NIBP)||21 CFR 870.1130||DXN|
|Respiratory Rate/Breathing Frequency||21 CFR 868.2375||BZQ|
|Electronic Stethoscope||21 CFR 870.1875||DQD|
“Allowing these devices to be used remotely can help healthcare providers access information about a patient’s vital signs while the patient is at home, reducing the need for hospital visits and minimizing the risk of exposure to coronavirus,” said FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD. “This policy reflects the FDA’s commitment to ease burdens on health care providers and facilities as they face this public health emergency. Such devices include technologies capable of enabling remote interactions to provide crucial information to be used as an adjunctive when health care providers diagnose or treat COVID-19 or co-existing conditions. During this public health emergency, it is imperative that the FDA provide regulatory relief and adapt as the situation warrants to act upon measures to save lives.”
This policy applies to certain modifications to the indications, claims, functionality, or hardware or software of FDA-cleared noninvasive remote monitoring devices used to support patient monitoring. This policy is limited to the duration of the emergency.