The Food and Drug Administration (FDA), the US authority responsible for medical devices regulation, issued guidance dedicated to enforcement policy for non-invasive remote monitoring devices used to support patient monitoring during the coronavirus disease 2019 (COVID-19).
Scope and Background Overview on Remote Monitoring Devices
During the public health emergency announced in the US due to the outbreak of the coronavirus disease (COVID-19) caused by the virus SARS-CoV-2 or “novel coronavirus”, the FDA is focused on taking effective steps aimed at providing medical device industry representatives and other parties involved in responding the pandemic with all necessary information and regulatory support.
It is also important to mention that due to the public health emergency, the document should be immediately implemented. At the same time, industry representatives still may provide their comments.
The Agency emphasizes the importance of data that could be collected using remote patient monitoring devices providing the possibility to collect all necessary data without arranging the physical presence of patients in healthcare facilities that allows to reduce substantially the number of patients visiting healthcare institutions. Thus, these devices are useful for reducing both risks arising from visiting healthcare institutions and the burden these institutions faced due to the outbreak of the infection.
The scope of the guidance covers the devices used to measure common physiological parameters and also used to maintain patient monitoring. In particular, the list of such devices includes:
- Cardiac monitor,
- Electrocardiograph (ECG),
- Electrocardiograph software for over-the-counter use,
- Electronic Stethoscope,
- Clinical electronic thermometer,
- Pulse Oximetry (SpO2),
- Respiratory Rate/Breathing Frequency,
- Non-invasive Blood Pressure.
The design of the aforementioned devices allows them to use wireless connections (e.g. Bluetooth, Wi-Fi or cellular connection) to connect to the network. Such a connection could be used to transmit data collected from the patient to a healthcare institution.
Depending on the particular device, it is possible to process the initial data collected by the device itself in order to transform this data into the information that could be directly used by healthcare professionals for diagnosing purposes.
Regulatory Approach on Remote Monitoring Devices
The Agency states that using remote monitoring devices allows healthcare institutions to establish efficient monitoring systems to maintain continuous monitoring without the need to contact directly with the patients since such contacts expose healthcare professionals and other patients to additional risks caused by the infection. To provide medical device manufacturers with the support they need due to the increasing demand on such devices, the Agency states that it actually allows limited modifications to the indications, claims, functionality, hardware or software of the devices already approved by the Agency. Such a specific regime would remain available within the whole period of the public health emergency. According to this exclusion, medical device manufacturers are allowed to make certain modifications without filing the appropriate submission to the Agency in advance.
In particular, this exclusion could be applied in the following cases:
- The inclusion of monitoring statements connected with the coronavirus disease,
- Changes to the instructions for use or initial claims provided by the manufacturer allowing home use of the devices (for ones initially intended for in-hospital use only),
- Changes to the hardware or software aimed at the improvement of the monitoring capability of the device.
Allowed Modifications to Remote Monitoring Devices in Detail
The document provides a detailed description of all changes that could be subject to new exclusion rules allowing medical device manufacturers to implement such changes to the remote patient monitoring devices without prior submission to the regulating authority.
As it has been already mentioned before, the Agency would not object to making modifications to the indications, claims of the functionality of the remote monitoring devices previously approved by the FDA unless such modifications create additional risk. According to the guidance, this approach could be applied when the following criteria are met:
- The initial intended purpose of the device as determined by the manufacturer is to display, print or analyze the data collected by the device (represented by one or several physiological parameters the device is intended to measure).
- The initial intended purpose of the device as determined by the manufacturer is to provide healthcare professionals using it with additional support or recommendations related to preventing, diagnosing or treating the coronavirus disease.
- The information used by the device to generate any diagnostic or treatment recommendations is accessible by the patient himself or the healthcare professional.
The document also provides examples of situations when, according to the position of the regulating authority, modifications made to the remote monitoring device could lead to additional risk arising. The list suggested by the Agency inter alia includes the situations when:
- The intended purpose of the device is to define whether the immediate clinical intervention needed,
- The intended purpose of the device is to provide healthcare professionals and patients with the information they would solely rely upon when making decisions regarding diagnosis or treatment of the coronavirus disease,
- The modifications the manufacturer intends to make to the device will allow to obtain or process a signal from another system that was not previously used in similar devices duly approved by the FDA.
It is also explicitly stated by the Agency that the labeling of the device should be amended to include certain additional information other than usually required in accordance with the applicable requirements. The Agency recommends to add such information in order to assist healthcare professionals and patients using the device to understand the modifications better.
The information the Agency recommends to include to the labeling should cover the following aspects:
- A detailed description of all new indications, claims of functions of the device related to the coronavirus disease and conditions associated thereto (the data on the performance of the device, the method used to determine recommendations the device provides, and the description of potential risks associated with the device);
- A notice informing that the information and recommendations provided by the device should be used as supportive information and any decisions related to diagnosing and treating should not be based solely on the recommendations provided by the device, addressed to healthcare professionals and patients using the device,
- Details on the particular way the device should be used (e.g. continuous monitoring or spot-checking, or trend monitoring).
- All indications and claims that were not approved by the FDA should be clearly separated from ones duly approved by the FDA. It is also advised to add a statement describing the changes made to the device that was not approved by the authority.
- In case if the device has been previously approved to be used in healthcare institutions, the indication made by the manufacturer allowing the in-home use of the device should be accompanied by the appropriate instructions describing in detail the way the device should be used in a safe and efficient manner.
Summarizing the information provided hereabove, the FDA allowed medical device manufacturers to make certain modifications to remote monitoring devices, collecting and processing physiological data from the patients, without submitting prior premarket notification to the Agency. This decision is aimed to assist medical device manufacturers in meeting the high demand for the devices they faced.
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