Amid the continuing impact of the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) has updated its guidelines on non-invasive remote monitoring devices that are essential for at-home patient care.
These changes replace guidelines from March 2020. They were initially intended to be temporary and only in effect for the duration of the pandemic. However, as outlined in the updated guidelines, the FDA will continue to permit the use of most remote monitoring devices (with the exception of oximeters and clinical electronic thermometers) in home settings.
This shift comes in response to the healthcare demands of the pandemic, which has led to an increased reliance on remote and at-home monitoring technologies. These changes will provide healthcare providers with necessary flexibility, while promising to maintain the safety and efficacy of at-home patient care.
For a more in-depth legal examination of these changes to the FDA’s policy, visit JD Supra’s detailed analysis by Hogan Lovells.