Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology: Guidance for Industry and Food and Drug Administration Staff

Issue Date: September 29, 2023
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, Combination Products, Clinical – Medical, Digital Health
Status: Final

Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology: Guidance for Industry and Food and Drug Administration Staff

This guidance document provides the FDA’s recommendations on design considerations, non-clinical testing, animal studies, and labeling to support premarket submissions for medical devices with physiologic closed-loop control technology. This guidance applies to the design and testing of a device incorporating physiologic closed-loop control technology. The design and testing will depend on a variety of factors, including, but not limited to, the energy or article being delivered, environment of use, level of automation, training of the user population, patient population, properties of the physiologic-measuring sensor, method of control algorithm design, and properties of the delivery system. The recommendations are intended to promote consistency and facilitate efficient review of medical devices with physiologic closed-loop control technology submissions.

Download the Guidance Document