> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Physiologic Closed-Loop Control Guidance
- URL: https://www.fdaweb.com/physiologic-closed-loop-control-guidance-2/
- Published: 2023-09-28T12:00:00.000Z
- Updated: 2026-09-14T18:59:01.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155444

FDA has published a guidance, *Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology*, to ensure safe and effective use and provide recommendations for the content of premarket submissions. The [document](https://www.fda.gov/media/154994/download?ref=fdaweb.com) says Physiologic Closed-Loop Control (PCLC) technology “can enable automation in a variety of medical device types. Such devices have the potential to deliver timely, accurate, and consistent therapy and can play an important role in reducing cognitive overload, minimizing human error, and enhancing medical care, including, for example, during emergency response and medical surge situations.”

The guidance includes an Introduction, Background, Scope, Definitions, Design Considerations for PCLC Devices, Non-Clinical Testing Considerations, Human Factors Testing, and Labeling.