Post-COVID, FDA still permits changes to non-invasive remote monitoring devices without 510(k)

Last week, the U.S. Food and Drug Administration (FDA) issued an immediately-in-effect guidance on its “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring,” which supersedes the March 2020 guidance titled “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency,” which was last revised in October 2020.

Non-invasive remote monitoring devices are used to obtain patient physiological data while reducing the need for in-office or in-hospital services. During the COVID-19 pandemic, FDA initially published the guidance to facilitate remote patient monitoring in light of the special risks to patients and health care providers posed by exposure to COVID-19. The COVID-era policy allowed previously cleared devices to be modified to respond to the need for access to a greater number of remote monitoring tools to both provide care to patients at home and also to keep patients out of already overloaded healthcare facilities where that was a viable option. However, the guidance only initially purported to last through the end of – and transition out of – the PHE.

Many of us hoped that the positive learnings from the pandemic would result in the retention of certain policies and this is a clear example of that happening.  As the PHE is winding down, FDA has published a revised version of the guidance that extends many of the enforcement policies for non-invasive remote monitoring devices that were set forth in March 2020, citing how “lessons learned” during the pandemic show that “the public health equities weigh in favor” of extending the policies. Yet, FDA pledges to “continue to monitor the situation and may make further revisions to the guidance, withdraw the guidance, or pursue other regulatory actions, as appropriate.”

Specifically, the guidance states that for the non-invasive remote monitoring devices covered by the policy (“subject devices”), FDA will permit “limited modifications to the indications, functionality, or hardware or software” without prior submission of a premarket notification (510(k)) where such submission would be required, “when the modification does not create undue risk and does not directly affect the physiological parameter measurement algorithm.” Examples of modifications to subject devices that FDA intends to permit with an additional 510(k) filing include:

• for subject devices previously marketed only for use in hospitals or other health care facilities, a change to the indications regarding use in the home setting; and,

• hardware or software changes to allow for increased remote monitoring capability.

In accordance with the wind-down of the PHE, notably removed from this list is the prior-existing example of “monitoring statements related to patients with COVID-19 or co-existing conditions.”

The enforcement policies described in the revised guidance apply to the same types of subject devices that were last listed in FDA’s October 2020 version of the guidance, except that FDA removed from the scope of the guidance the oximeter and clinical electronic thermometer device types.

In the theme of omitting COVID-19-specific information from the revised version of the guidance, FDA has removed the section entitled “Clinical Decision Support Software for Monitoring related to COVID-19 and Co-existing Conditions,” which permitted modifications without a new 510(k) filing for certain CDS software.

The revised version of the guidance contains two other minor changes:

• International QS harmonization. FDA added into the guidance a reference to its proposal to amend the device current good manufacturing practice (CGMP) requirements of the quality system (QS) regulation (21 CFR part 820), to align more closely with the international consensus standard for devices by converging with the quality management system (QMS) requirements used by other regulatory authorities from other countries. FDA cites this proposal in defense of its new recommendation in the latest revised guidance that a medical device “manufacturer must document the change and analysis in accordance with the manufacturer’s quality system.”

• “Health equity” prioritization. FDA adds into the revised guidance a policy statement that the new version is “consistent with [Center for Devices and Radiological Health’s (CDRH)] 2022-2025 strategic priorities focusing on advancing health equity, which includes increasing access to digital health technologies that can advance better care, quality of life, and wellness of diverse populations.”

Next steps

If you have questions on the guidance, please contact the authors of this alert or the Hogan Lovells attorney with whom you generally work.

Authored by Randy Prebula and Jodi Scott.