- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological Health
FDA is issuing this guidance to provide clarification on its enforcement policies and premarket review expectations for certain non-invasive remote monitoring used for patient monitoring at the conclusion of the COVID-19 public health emergency. FDA believes the policy set forth in this guidance may help FDA and other stakeholders transition from COVID-19 operations and processes to normal operations and processes.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2023-D-4356.