FDA allows expanded use of patient-monitoring devices during pandemic

The FDA announced today that it will allow expanded use of non-invasive remote patient monitoring devices to slow the spread of COVID-19 and ease the burden on hospitals and healthcare providers.

In a new guidance, the agency said the policy will expand the availability and capability of
such devices to enable patient monitoring and reduce patient/provider contact and exposure to COVID-19. The guidance will only be in effect for the duration of the public health emergency.

Devices covered by the guidance could 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. Some may also apply algorithms to transform a patient’s vital signs into a novel index or alarm that may aid a health care professional in the diagnosis of a particular condition or disease state/severity, according to the agency.

Non-invasive remote-monitoring devices covered by the new guidance are:

• Clinical electronic thermometers.
• Electrocardiograph machines (ECG).
• Cardiac monitors.
• Electrocardiograph software for over-the-counter use.
• Pulse oximeters.
• Non-invasive blood pressure devices.
• Respiratory rate/breathing frequency measurement devices.
• Electronic stethoscopes.

The FDA said that it does not intend to object to limited modifications to the indications, claims, functionality, or hardware or software of previously cleared devices that fall into these categories without requiring manufacturers to apply for additional 510(k) clearance or premarket notification. Examples of such modifications are:

• The inclusion of monitoring statements related to patients with COVID-19 or co-existing
  conditions (such as hypertension or heart failure).
• Home-based use of subject devices previously cleared only for use in hospitals or other health care facilities.
• Hardware or software changes to allow for increased remote-monitoring capability.

The full guidance may be found here.