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.
Other agency actions in response to the COVID-19 public health emergency include an enforcement policy for ventilators and accessories along with other respiratory devices as well as a policy issued earlier this month allowing laboratories to develop and begin using diagnostic tests for the coronavirus before FDA has completed a review of their Emergency Use Authorization requests.
As part of this emergency enforcement policy for non-invasive remote patient monitoring devices, FDA does not intend to object to modifications to the FDA-cleared indications, claims, or functionality of these 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 health emergency,” FDA wrote. “Increased utilization of non-invasive remote patient monitoring devices may ease burdens on hospitals and other healthcare facilities and reduce the risk of exposure for patients and health care providers to SARS-CoV-2.”
The policy outlines several acceptable modifications. For instance, Bradley Merrill Thompson, a member of the firm, Epstein Becker & Green, P.C., pointed out that FDA is “allowing hardware used in remote monitoring to be marketed with expanded claims that may include reference to the particular coronavirus disease 2019. That's very helpful,” he wrote in an email to MD+DI. “There are a lot of people looking for solutions in telemedicine and remote monitoring who may be able to use a broader set of products than those that have been specifically cleared for this use previously.” He also said that the agency is allowing some hardware modifications to make them more suitable for the current need, such as adding Bluetooth or other connectivity means. “This, too, is very sensible and should not add much risk,” he wrote.
FDA’s temporary policy also acknowledged that software, including mobile apps, may also prove useful in patient monitoring during the pandemic. The agency points out that The 21st Century Cures Act amended FDA regulations to exclude certain software functions from the definition of a medical device, including certain clinical decision support (CDS) software functions. Thompson pointed out that with this emergency policy “FDA is waiving the limitation on CDS for the present emergency to allow the development of clinical decision support products that offer advice on diagnosing and treating coronavirus disease 2019. There are limits of course,” he wrote. “They recommend what I think are very practical labeling statements to help the user understand how the product can be used and how it shouldn't be used.”
FDA wrote that it would still receive and consider comments on the guidance under docket number FDA-2020-D-1138. Electronic comments can be submitted at https://www.regulations.gov.