The U.S. Food and Drug Administration (“FDA”) has recently published the revised guidance on Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the COVID-19 Public Health Emergency (“Guidance”) which supersedes the version issued on March 20, 2020. With the revision, additional device types and references and standards for consideration are included to the scope of the Guidance.
The Guidance aims to ease public health concerns by expanding the capability of remote monitoring devices to reduce the need for face-to-face patient management during COVID-19 pandemic. FDA has explained increased utilization of non-invasive remote patient monitoring devices may ease burdens on hospitals and other healthcare facilities and therefore reduce the risk of exposure for patients and health care providers to COVID-19.
Accordingly, the non-invasive remote monitoring devices under the scope of the Guidance are explained to have the potential to be connected to a wireless network to transmit a patient’s measurements directly to their health care provider or other monitoring entity and to apply algorithms to transform a patient’s physiological parameters into a novel index or alarm that may aid a health care professional in the diagnosis of a particular condition or disease state. Pursuant to the Guidance, FDA does not intend to object to limited modifications without prior submission of a premarket notification during the declared public health emergency.
Modifications to indications, claims, or functionality
In light of the public health emergency, modifications to indications, claims, or functionality of the determined non-invasive remote monitoring under the Guidance will be allowed by the FDA without prior submission of a premarket notification provided that the modification does not create an undue risk.
With this respect, FDA considers the modification to create such undue risk if:
i. the device is intended to determine the need for immediate clinical intervention;
ii. the device is intended to be solely or primarily relied upon to make a clinical diagnosis or treatment decision pertaining to COVID-19 or coexisting conditions; or
iii. the modifications add the functionality to acquire, process, or analyze a pattern or signal from a signal acquisition system that was not previously present in the subject device.
Modifications to hardware or software
Pursuant to the Guidance, modifications to hardware or software architecture intended to increase remote monitoring capability will be allowed by the FDA without prior submission of a premarket notification provided that the modification does not create an undue risk and that the modifications do not directly affect the physiological parameter measurement algorithms, such as addition of wireless or Bluetooth capability.
With this respect, FDA recommends the manufacturers to design and evaluate such modifications in compliance with mentioned standards under the Guidance and to implement appropriate cybersecurity controls to maintain device functionality and safety.
FDA recommends that the devices described under the Guidance to use labeling that includes elements such as description of the available data on the subject device’s new indications, claims, or functions related to COVID-19 or co-existing conditions such as hypertension heart failure; notification that recommendations provided by the subject device are not intended to be used as a primary means to make diagnosis, prevention, or treatment recommendations; general statement about changes that have not been cleared by FDA, etc.
In addition, a Memorandum of Understanding (“MOU”) has been executed between FDA, the U.S. Customs and Border Protection, and the U.S. Immigration and Customs Enforcement, and Homeland Security Investigations to prevent harmful products that threaten public health and attempt to enter the U.S. through International Mail Facilities and to increase inspection and detection capabilities. Accordingly, among other agenda items, the parties to the MOU will aim to prevent fraudulent, counterfeit, or illegitimate COVID-19 products.