2023-23110: Enforcement Policy for Non-Invasive Remote Monitoring Devices Used To Support Patient Monitoring; Guidance for Industry and Food and Drug Administration Staff; Availability
Get alerted when the next rule lands
New rules open for comment on their own schedule. Pick how you want to hear about them — we email you when one appears.
Publishing to members? Embed a live rule tracker on your own site — the proposed rules in your area and the comment deadlines closing on them, updating themselves. Free, one line of HTML.
Create a free account & build one →Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring." The enforcement policy described in this guidance applies to modified devices where the original device was a legally marketed, non-invasive remote monitoring device listed in the guidance that measures or detects common physiological parameters and that is used to support patient monitoring. The guidance is intended to describe the enforcement policy for limited modifications to the indications, functionality, or hardware or software of device types in the scope of the guidance without prior submission of a 510(k) where such submission would be required.
The agency’s own summary, as published.
Don't miss the comment window
One Click Politics alerts you on every deadline, hearing, and rule change.
See all rules with comments due soon →