FDA Issues Guidance to Limit Physician-Patient Contact
On March 20, 2020, The FDA issued guidance for expanded use of certain remote monitoring devices to facilitate patient management while limiting physician-patient contact during the COVID-19 pandemic. It 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 body temperature, respiratory rate, heart rate and blood pressure.
The specific devices mentioned in the guidance are clinical electronic thermometers, ECGs, cardiac monitors, electrocardiograph software for over-the-counter use, pulse oximeters, devices to measure respiratory rate and breathing frequency, and electronic stethoscopes.
The guidance, which is intended to provide regulatory relief during the public health crisis, has been issued with immediate effect, without prior public comment, and is to remain in place only as long as the outbreak remains a declared public health emergency.
The FDA believes the policy will help address these urgent public health concerns by helping to expand the availability and capability of remote patient monitoring devices. Modified use of these devices may increase access to important patient physiological data without the need for in-clinic visits and facilitate patient management by health care providers while reducing the need for in-office or in-hospital services during the COVID-19 public health emergency.
The data gathered via the devices can be used when healthcare providers diagnose or treat COVID-19 or coexisting conditions, the FDA said. The policy allows devices originally only cleared for healthcare settings to be used in the home setting.
Some of these devices also have the potential to apply algorithms to turn a patient’s physiological data into an index or alarm that may aid in diagnosing or assessing the severity of a condition that can assist a health care professional in the diagnosis of a particular condition or disease state/severity.
Under the guidance, the FDA may allow for modifications to the hardware or software of the specified devices, which will enhance their remote usability.
Additionally, so long as they do not lead to unduly elevated risks, the FDA may allow amendments to approved indications, claims or functionalities of the devices without prior submission of a premarket notification. However, such modifications would be objected to if, for example, the device is intended to determine when patients need immediate clinical intervention or is to be primarily relied upon for making clinical diagnoses or treatment decisions concerning COVID-19 or coexisting conditions, as such alterations would create undue risk.
The remote patient monitoring device guidance applies to non-invasive devices that can be connected to a wireless network through Bluetooth, Wi-Fi, or cellular connection to transmit a patient’s measurements directly to their healthcare provider or other monitoring entity.
In making way for an increase in remote monitoring, FDA is waiving a limitation on clinical decision support (CDS) software to now allow for the development of products that can provide advice on diagnosing and treating the coronavirus.