FDA Issues Emergency Guidance for Non-Invasive Remote Monitoring Devices

In an effort to ease remote patient monitoring during the COVID-19 pandemic, FDA has issued the temporary guidance, “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” This guidance is effective immediately, without prior industry or public comment, and it will remain in effect during the duration of the public health emergency. As part of the enforcement policy, FDA does not intend to object to modifications to the FDA-cleared indications, claims, or functionality of non-invasive remote-monitoring devices without prior submission of a premarket notification where the modification does not create an undue risk in light of the public health emergency, the agency explained. In addition, FDA does not intend to object to hardware or software architecture modifications to devices that allow for increased remote monitoring to support additional claims or indications without prior submission of a premarket notification as long as the modifications do not directly affect the physiological parameter measurement algorithms, the agency added. “Modified use of these devices may increase access to important patient physiological data without the need for in-clinic visits and facilitate patient management by health care providers while reducing the need for in-office or in-hospital services during the COVID-19 public he...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news