The Food and Drug Administration (FDA) continues to churn out policy statements, guidance documents, and emergency use authorizations (EUAs) to address the COVID-19 public health emergency. At the outset of the pandemic in early 2020, the agency concentrated its efforts on measures relating to devices that may help directly diagnose, treat, or prevent COVID-19, such as facemasks, ventilators, and diagnostic test kits. Recently, however, FDA appears to have shifted its focus to devices that may assist in the defense against the spread of COVID-19. For example, FDA issued enforcement policies and EUAs that help to expand the availability and capability of various remote monitoring devices and systems that can be used to diagnose and monitor medical conditions while mitigating circumstances that could lead to patient and health care workers’ exposure to SARS-CoV-2 (the virus that causes COVID-19) for the duration of the public health emergency.
In prior posts, we’ve covered FDA policy changes aimed at expanding face masks, face shields, respirators, and diagnostic kits (see prior posts here and here). In addition, we’ve covered the agency’s diverse enforcement actions regarding the manufacture and distribution of face masks and filtering face piece respirators during the COVID-19 emergency (see prior post here). Now, FDA has addressed use of remote patient monitoring and imaging devices during the pandemic, and it is likely that the agency will continue to explore additional policies relaxing restrictions for a broader range of medical products with potential uses during the pandemic in the hope of slowing the spread of the virus. This post highlights recent FDA actions expanding the use of medical devices that may assist hospitals and healthcare professionals in monitoring patients without risking additional exposure to SARS-CoV-2.
Recent Enforcement Discretion Policies
Patient Monitoring Systems Enforcement Policy
On April 23, 2020, FDA issued guidance expanding the availability of non-invasive fetal and maternal monitoring devices, such as devices that measure or detect fetal heart rate, maternal heart rate, and/or uterine activity, used to support patient monitoring during the COVID-19 emergency (see guidance here). The guidance intends to facilitate remote patient monitoring while reducing patient and health care provider contact and therefore potential exposure to SARS-CoV-2.
Specifically, the guidance applies to currently legally marketed fetal dopplers and fetal and maternal monitoring devices that can be used by health care providers via prescription in a home setting. FDA does not intend to object to limited modifications to the indications, functionality, hardware, and/or software of FDA-cleared non-invasive fetal and maternal monitoring devices to enable remote monitoring by a physician, so long as the modifications do not create an undue risk to users. The policy describes circumstances in which FDA would not consider such limited modifications to those devices as creating undue risk. In addition, FDA requires manufacturers to validate any such modifications to fetal and maternal monitoring devices in accordance with relevant FDA-recognized standards. Any limited modifications to fetal and maternal monitoring devices in compliance with the enforcement policy will not require premarket notification prior to implementation and use.
Imaging Systems Enforcement Policy
In another enforcement policy released on April 23, 2020, FDA describes options to increase the availability of mobile and portable radiological imaging systems, including both hardware imaging systems and image analysis software, with the aim of easing the burden on health care workers and institutions that are experiencing an increased demand for patient imaging due to COVID-19 (see guidance here). In addition to increasing the availability of imaging systems, FDA intends the policy to allow patients to undergo imaging procedures outside of large health care facilities, thus limiting potential exposure to SARS-CoV-2, and to assist health care professionals in the diagnosis and monitoring of conditions.
The enforcement policy is organized into separate sections that describe examples of modifications to specific subsets of devices (e.g., ultrasound imaging systems and image analysis software) and circumstances under which such modifications would not create undue risks to users or patients. As with the non-invasive fetal and maternal monitoring devices enforcement policy, manufacturers must validate any such modifications to imaging devices in accordance with FDA-recognized standards. Any modifications made to the specified imaging devices in compliance with the enforcement policy will not require submission of a premarket notification or a premarket approval application.
Remote Digital Pathology Devices Enforcement Policy
On April 24, 2020, FDA released an enforcement policy to increase the availability of devices intended for remote reviewing and reporting of digital pathology slides during the pandemic (see guidance here). By expanding access and use of remote digital pathology devices, FDA hopes to improve continuity of care while reducing health care personnel contact with patients and risk of exposure to SARS-CoV-2.
In particular, FDA does not intend to require manufacturers to comply with premarket notification, quality management system, and unique device identification requirements for (1) modifications to indications, functionality, hardware or software to enable remote use of digital pathology devices that are already legally on the market, or (2) the commercialization of new digital pathology devices intended for remote use that are not currently FDA-cleared for any use, as long as such modifications do not create an undue risk. The enforcement policy also provides the agency’s recommendations relating to labeling, evaluation to applicable FDA-recognized standards, and cybersecurity controls, which will help ensure the remote digital pathology devices do not create undue risk.
Emergency Use Authorizations for Remote Patient Monitors
To date, FDA has issued EUAs to two companies for remote patient monitoring devices. The first was issued on April 21, 2020 for Philips Medizin Systeme Boeblingen GmbH’s IntelliVue Patient Monitors (see Authorization Letter here). The IntelliVue monitors are intended for use by health care professionals in a hospital environment for remote monitoring of adult, pediatric, and neonate COVID-19 patients. FDA determined that the IntelliVue monitors may be effective for remotely monitoring physiological signals from patients in hospitals, thus reducing health care provider exposure to SARS-CoV-2 during the COVID-19 pandemic.
On April 27, 2020, FDA issued a second EUA for a remote patient monitoring device, VitalConnect, Inc.’s VitalPatch Biosensor, which intended to be used by health care professionals in the hospital setting for remote monitoring and detection of changes in the QT interval of an electrocardiogram (“ECG”) for patients undergoing treatment for COVID-19 (see Authorization Letter here). The device may be used by COVID-19 patients being treated with drugs that can prolong the QT interval and may cause life-threatening arrhythmia. Examples provided by the EUA include “hydroxychloroquine or chloroquine, especially when used in combination with azithromycin.” Again, such remote monitoring may reduce health care professional exposure to COVID-19.
Unless otherwise specified, none of the EUA-authorized devices are intended for home use.
Why the Agency Shift in Focus Matters
FDA’s expansion of devices authorized to combat COVID-19 and mitigate risk during the pandemic is notable, particularly the relaxation of stringent enforcement and compliance measures for remote monitoring and imaging devices that typically require FDA clearance or approval. If the agency’s measures prove to be effective during the emergency, the question on everyone’s mind is whether the relaxed regulatory standards will become the new norm?
The simple answer is probably not. The FDA policies reducing certain regulatory strictures clearly state that such targeted enforcement discretion is temporary and will end as soon as the public health emergency ends. In most cases, the regulatory flexibility narrowly applies to devices that are already FDA-cleared or approved and that are modified in accordance with the relevant policy. For the policies that do apply to devices that are not cleared, approved, or legally marketed in the US, it is almost certain that FDA will not extend such enforcement exceptions beyond the duration of the public health emergency because the agency will need to reassert its oversight to assure the safety and effectiveness of such devices. Similarly, the EUAs are temporary by nature and set up specific indications and conditions for the use of devices that are not otherwise cleared or approved for such indications. It therefore stands to reason that FDA would not allow such uses to continue absent premarket notification or submission of premarket approval applications, as applicable.
However, the temporary regulatory flexibility is noteworthy in that it illustrates a possible trend the agency may continue during this public health emergency and may employ again during future emergencies. As noted above, prior to the most recent enforcement policies and EUAs, FDA appeared to focus on creating regulatory flexibility for devices that could directly assist health care workers in treating COVID-19 patients. On the other hand, the newer enforcement policies and EUAs highlight a broader approach by FDA to authorize modifications to existing devices, or even new, not cleared or approved devices, that may enable evaluation and treatment of patients with and without COVID-19 and whose use may aid in slowing the spread of COVID-19 by limiting contact between different patient populations and between patients and health care workers.
Although it is unlikely that we will see a permanent change in the level of FDA oversight of medical devices once the public health emergency ends, it is possible that the broader use of certain devices allowing remote monitoring or remote review of medical images may demonstrate to FDA that such devices may be used safely and effectively for such uses, thereby paving the way for more efficient premarket review processes for such devices in the future. As the pandemic continues, however, FDA is likely to continue its current trajectory of regulatory flexibility towards remote monitoring devices and will continue to employ the tools at its disposal to flatten the infection curve.