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FDA Guidance on the emergency exemption for non-invasive Remote Patient Monitoring devices

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The FDA is expanding its support for Remote Patient Monitoring Devices and tools that help with monitoring patients for COVID-19 patients.

From the FDA website.

The FDA is expanding its support for Remote Patient Monitoring Devices and tools that help with monitoring patients for COVID-19 patients.

The FDA is waiving the low-risk limitation on clinical decision support including AI for the present emergency to allow the development of CDS products that offer advice on diagnosing and treating the coronavirus. They are allowing hardware used in remote monitoring to be marketed with expanded claims that may include a reference to the particular virus.

The FDA is also allowing some hardware modifications to make them more suitable for the current need, such as adding Bluetooth and other ways of connecting.

In the context of the COVID-19 public health emergency, the leveraging of current non-invasive patient monitoring technology will help eliminate unnecessary patient contact and ease the burden on hospitals, other health care facilities, and health care professionals that are experiencing increased demand due to the COVID-19 pandemic as it relates to diagnosis and treatment of patients with COVID-19 and ensuring other patients who require monitoring for conditions unrelated to COVID19 can be monitored outside of health care facilities. For that reason, FDA does not intend to object to limited modifications to the indications, claims, functionality, or hardware or software of FDA cleared non-invasive remote monitoring devices that are used to support patient monitoring (hereinafter referred to as “subject devices”) during the declared public health emergency, as described in more detail below, without prior submission of a premarket notification under section 510(k) of the FD&C Act and 21 CFR 807.81.5

Examples of such modifications include:

• The inclusion of monitoring statements related to patients with COVID-19 or co-existing conditions (such as hypertension or heart failure);

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

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