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GUIDANCE DOCUMENT

Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring Guidance for Industry and Food and Drug Administration Staff October 2023

Final
Docket Number:
FDA-2023-D-4356
Issued by:
Guidance Issuing Office
Center 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.


Submit Comments

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:

Dockets Management
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.

 
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