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# Physiologic Closed-Loop Control Guidance
- URL: https://www.fdaweb.com/physiologic-closed-loop-control-guidance/
- Published: 2022-01-03T12:00:00.000Z
- Updated: 2026-09-14T17:26:57.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150824

FDA has published a draft guidance, *Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology*, highlighting technical considerations for the development of medical devices employing physiologic closed-loop control technology to ensure safe and effective use. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/technical-considerations-medical-devices-physiologic-closed-loop-control-technology?ref=fdaweb.com) also provides recommendations for the content of premarket submissions — 510(k)s, de novo requests, PMAs, and HDEs — for such devices.

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