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GUIDANCE DOCUMENT

Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology Guidance for Industry and Food and Drug Administration Staff September 2023

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2021-D-0996
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

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. 

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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-2021-D-0996.

 
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