The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released a final guidance "Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring" last week (19 October 2023).
Non-invasive remote monitoring devices are used to acquire patient physiological data without the need for in-clinic visits and facilitate patient management by healthcare providers while reducing the need for in-office or in-hospital services.
This guidance clarifies FDA's enforcement policies and premarket review expectations for certain noninvasive remote monitoring used for patient monitoring following the conclusion of COVID-19. This guidance may help FDA and other stakeholders transition from COVID-19 operations and processes to normal operations and processes.
The enforcement policy described in this guidance applies to modified devices where the original device was a legally marketed, non-invasive remote monitoring device that measures or detects common physiological parameters and that is used to support patient monitoring.
The manufacturers of non-invasive remote monitoring devices must follow FDA regulations, including submitting a premarket notification under section 510(k) and obtaining FDA clearance before they can market these devices in the United States. This requirement applies unless the devices are exempt from the 510(k) process. Additionally, they must adhere to post-marketing obligations.
To know more about the Modifications to Indications or Functionality etc., click this LINK.
Also, check out this final guidance "Development and Licensure of Vaccines to Prevent COVID-19" released on 19th October, 2023 by CBER to to assist sponsors in the clinical development and licensure of vaccines for the prevention of Coronavirus Disease 2019 (COVID-19) which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).