FDA revises final guidance on modifying remote monitoring devices

The US Food and Drug Administration (FDA) has updated final guidance on its enforcement policy for remote patient monitoring devices in an effort to assist stakeholders in transitioning operations and processes following the end of the COVID-19 public health emergency (PHE).

The original iteration of the final guidance, issued in March 2020 during the early days of the COVID-19 pandemic, was intended to inform stakeholders that FDA would not object to certain limited modifications of non-invasive remote monitoring devices used for patients during the COVID-19 public health emergency (RELATED: FDA Offers Flexibility for Changes to Non-Invasive Remote Monitoring Devices During Pandemic, Regulatory Focus 20 March 2020).

Later versions of the guidance, published in June 2020 and updated in October 2020, expanded the number of remote monitoring devices covered by the enfocement policy (RELATED: FDA expands guidance on remote monitoring devices for COVID-19, Regulatory Focus 08 June 2020).

When the federal PHE for COVID-19 ended in May 2023, the agency expressed interest in continuing with policies outlined in the guidance.

“FDA’s experience has demonstrated that the public health equities weigh in favor of exercising certain enforcement policies for these devices beyond the expiration of the COVID-19 PHE,” agency officials wrote. “More specifically, FDA has evaluated the benefits and risks to patients and healthcare providers of exercising certain enforcement policies, including identifying certain device types for which enforcement policies might be appropriate, and assessing other lessons learned from implementation of COVID-19-related enforcement policies for certain device types.”

FDA’s new final guidance contains a few changes from previous versions. For instance, the agency removed the oximeter and clinical electronic thermometer from a table of legally marketed non-invasive remote monitoring devices that were included in earlier iterations of the final guidance.

The agency said manufacturers should submit a 510(k) premarket notification for qualified non-invasive remote monitoring devices and receive clearance before marketing them in the US. FDA also reiterated that it would not object to “limited modifications to the indications, functionality, or hardware or software of certain non-invasive remote monitoring devices that are used to support patient monitoring,” such as moving a device from the hospital to the home setting, or making a hardware/software change that increases the ability to remotely monitor patients.

The goal of the final guidance is to “lessen the burden on both manufacturers and FDA by reducing the number of 510(k) submissions caused by certain modifications to allow for remote monitoring,” FDA wrote.

“In developing this policy, FDA’s intent is to foster the availability of certain non-invasive remote monitoring devices that can help eliminate unnecessary patient contact and ease burdens on hospitals, other health care facilities, and health care professionals, which are experiencing high demands,” the agency wrote in the updated guidance, issued on 19 October 2023.

Unlike the COVID-19 era version of the guidance, the latest final guidance has no expiration data, but FDA said it would continue to monitor feedback and revise the guidance as needed.

Final guidance

FDA revises final guidance on modifying remote monitoring devices

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