[FDA] Guidance - Enforcement policy for non-invasive remote monitoring devices used to support patient monitoring

[요약]

코로나때 긴급하게 사용되었던 원격모니터링 장비/기기에 대한 FDA 정책 변화를 가이던스로 발표하였다.

 

FDA is issuing this guidance to provide clarification on its enforcement policies and premarket review expectations for certain non-invasive remote monitoring used for patient monitoring at the conclusion of the COVID-19 public health emergency. FDA believes the policy set forth in this guidance may help FDA and other stakeholders transition from COVID-19 operations and processes to normal operations and processes.

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[Introduction]

The Food and Drug Administration (FDA or the Agency) plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic and public health emergencies (PHEs).

 

Following the emergence of COVID-19, FDA first issued this guidance in March 2020 to provide a policy to help expand the availability and capability of non-invasive remote monitoring devices to address the PHE. At the time, FDA stated that the policy described in this guidance was intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) in accordance with section 319 of the Public Health Service Act (PHS Act). On March 13, 2023, FDA announced in the Federal Register notice “Guidance Documents Related to Coronavirus Disease 2019 (COVID-19),” that this guidance document was being revised to continue in effect for 180 days after the COVID-19 PHE declaration expires, and that, during that time, FDA intends to further revise the guidance.

 

Non-invasive remote monitoring devices are used to acquire patient physiological data without the need for in-clinic visits and facilitate patient management by healthcare providers while reducing the need for in-office or in-hospital services. The policy set forth in this guidance was initially intended to facilitate patient monitoring while reducing patient and healthcare provider contact and exposure to COVID-19 by helping to expand the availability and capability of noninvasive remote monitoring devices during the COVID-19 PHE. Since first issuing the Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency guidance in March 2020, 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 (which expired on May 11, 2023) and the 180-day period announced in the March 13, 2023 Federal Register notice. 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. Although this guidance has been revised to remove any expiration date for the enforcement policy, among other things, FDA intends to continue to monitor the situation and may make further revisions to the guidance, withdraw the guidance, or pursue other regulatory actions, as appropriate.

 

 

Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring | FDA

Non-Invasive Remote Monitoring Enforcement Policy