The US Food and Drug Administration (FDA) has updated final guidance on its enforcement policy for remote patient monitoring devices in an effort to assist stakeholders in transitioning operations and processes following the end of the COVID-19 public health emergency (PHE).
The original iteration of the final guidance, issued in March 2020 during the early days of the COVID-19 pandemic, was intended to inform stakeholders that FDA would not object to certain limited modifications of non-invasive remote monitoring devices used for patients during the COVID-19 public health emergency (RELATED: FDA Offers Flexibility for Changes to Non-Invasive Remote Monitoring Devices During Pandemic, Regulatory Focus 20 March 2020).
Later versions of the guidance, published in June 2020 and updated in October 2020, expanded the number of remote monitoring devices covered by the enfocement policy (RELATED: FDA expands guidance on remote monitoring devices for COVID-19, Regulatory Focus 08 June 2020)…
